[111th Congress Public Law 31]
[From the U.S. Government Printing Office]
[[Page 1775]]
FAMILY SMOKING PREVENTION AND TOBACCO CONTROL AND FEDERAL RETIREMENT
REFORM
[[Page 123 STAT. 1776]]
Public Law 111-31
111th Congress
An Act
To protect the public health by providing the Food and Drug
Administration with certain authority to regulate tobacco products, to
amend title 5, United States Code, to make certain modifications in the
Thrift Savings Plan, the Civil Service Retirement System, and the
Federal Employees' Retirement System, and for other
purposes. <<NOTE: June 22, 2009 - [H.R. 1256]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
DIVISION A--FAMILY <<NOTE: Family Smoking Prevention and Tobacco Control
Act.>> SMOKING PREVENTION AND TOBACCO CONTROL ACT
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) <<NOTE: 21 USC 301 note.>> Short Title.--This division may be
cited as the ``Family Smoking Prevention and Tobacco Control Act''.
(b) Table of Contents.--The table of contents of this division is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
Sec. 6. Modification of deadlines for Secretarial action.
TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act.
Sec. 102. Final rule.
Sec. 103. Conforming and other amendments to general provisions.
Sec. 104. Study on raising the minimum age to purchase tobacco products.
Sec. 105. Enforcement action plan for advertising and promotion
restrictions.
Sec. 106. Studies of progress and effectiveness.
TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE
Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label statements.
Sec. 203. State regulation of cigarette advertising and promotion.
Sec. 204. Smokeless tobacco labels and advertising warnings.
Sec. 205. Authority to revise smokeless tobacco product warning label
statements.
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the
public.
TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
Sec. 301. Labeling, recordkeeping, records inspection.
Sec. 302. Study and report.
SEC. 2. <<NOTE: 21 USC 387 note.>> FINDINGS.
The Congress finds the following:
[[Page 123 STAT. 1777]]
(1) The use of tobacco products by the Nation's children is
a pediatric disease of considerable proportions that results in
new generations of tobacco-dependent children and adults.
(2) A consensus exists within the scientific and medical
communities that tobacco products are inherently dangerous and
cause cancer, heart disease, and other serious adverse health
effects.
(3) Nicotine is an addictive drug.
(4) Virtually all new users of tobacco products are under
the minimum legal age to purchase such products.
(5) Tobacco advertising and marketing contribute
significantly to the use of nicotine-containing tobacco products
by adolescents.
(6) Because past efforts to restrict advertising and
marketing of tobacco products have failed adequately to curb
tobacco use by adolescents, comprehensive restrictions on the
sale, promotion, and distribution of such products are needed.
(7) Federal and State governments have lacked the legal and
regulatory authority and resources they need to address
comprehensively the public health and societal problems caused
by the use of tobacco products.
(8) Federal and State public health officials, the public
health community, and the public at large recognize that the
tobacco industry should be subject to ongoing oversight.
(9) Under article I, section 8 of the Constitution, the
Congress is vested with the responsibility for regulating
interstate commerce and commerce with Indian tribes.
(10) The sale, distribution, marketing, advertising, and use
of tobacco products are activities in and substantially
affecting interstate commerce because they are sold, marketed,
advertised, and distributed in interstate commerce on a
nationwide basis, and have a substantial effect on the Nation's
economy.
(11) The sale, distribution, marketing, advertising, and use
of such products substantially affect interstate commerce
through the health care and other costs attributable to the use
of tobacco products.
(12) It is in the public interest for Congress to enact
legislation that provides the Food and Drug Administration with
the authority to regulate tobacco products and the advertising
and promotion of such products. The benefits to the American
people from enacting such legislation would be significant in
human and economic terms.
(13) Tobacco use is the foremost preventable cause of
premature death in America. It causes over 400,000 deaths in the
United States each year, and approximately 8,600,000 Americans
have chronic illnesses related to smoking.
(14) Reducing the use of tobacco by minors by 50 percent
would prevent well over 10,000,000 of today's children from
becoming regular, daily smokers, saving over 3,000,000 of them
from premature death due to tobacco-induced disease. Such a
reduction in youth smoking would also result in approximately
$75,000,000,000 in savings attributable to reduced health care
costs.
(15) Advertising, marketing, and promotion of tobacco
products have been especially directed to attract young persons
to use tobacco products, and these efforts have resulted in
increased use of such products by youth. Past efforts to oversee
[[Page 123 STAT. 1778]]
these activities have not been successful in adequately
preventing such increased use.
(16) In 2005, the cigarette manufacturers spent more than
$13,000,000,000 to attract new users, retain current users,
increase current consumption, and generate favorable long-term
attitudes toward smoking and tobacco use.
(17) Tobacco product advertising often misleadingly portrays
the use of tobacco as socially acceptable and healthful to
minors.
(18) Tobacco product advertising is regularly seen by
persons under the age of 18, and persons under the age of 18 are
regularly exposed to tobacco product promotional efforts.
(19) Through advertisements during and sponsorship of
sporting events, tobacco has become strongly associated with
sports and has become portrayed as an integral part of sports
and the healthy lifestyle associated with rigorous sporting
activity.
(20) Children are exposed to substantial and unavoidable
tobacco advertising that leads to favorable beliefs about
tobacco use, plays a role in leading young people to
overestimate the prevalence of tobacco use, and increases the
number of young people who begin to use tobacco.
(21) The use of tobacco products in motion pictures and
other mass media glamorizes its use for young people and
encourages them to use tobacco products.
(22) Tobacco advertising expands the size of the tobacco
market by increasing consumption of tobacco products including
tobacco use by young people.
(23) Children are more influenced by tobacco marketing than
adults: more than 80 percent of youth smoke three heavily
marketed brands, while only 54 percent of adults, 26 and older,
smoke these same brands.
(24) Tobacco company documents indicate that young people
are an important and often crucial segment of the tobacco
market. Children, who tend to be more price sensitive than
adults, are influenced by advertising and promotion practices
that result in drastically reduced cigarette prices.
(25) Comprehensive advertising restrictions will have a
positive effect on the smoking rates of young people.
(26) Restrictions on advertising are necessary to prevent
unrestricted tobacco advertising from undermining legislation
prohibiting access to young people and providing for education
about tobacco use.
(27) International experience shows that advertising
regulations that are stringent and comprehensive have a greater
impact on overall tobacco use and young people's use than weaker
or less comprehensive ones.
(28) Text only requirements, although not as stringent as a
ban, will help reduce underage use of tobacco products while
preserving the informational function of advertising.
(29) It is in the public interest for Congress to adopt
legislation to address the public health crisis created by
actions of the tobacco industry.
(30) The final regulations promulgated by the Secretary of
Health and Human Services in the August 28, 1996, issue of the
Federal Register (61 Fed. Reg. 44615-44618) for inclusion
[[Page 123 STAT. 1779]]
as part 897 of title 21, Code of Federal Regulations, are
consistent with the first amendment to the United States
Constitution and with the standards set forth in the amendments
made by this subtitle for the regulation of tobacco products by
the Food and Drug Administration, and the restriction on the
sale and distribution of, including access to and the
advertising and promotion of, tobacco products contained in such
regulations are substantially related to accomplishing the
public health goals of this division.
(31) The regulations described in paragraph (30) will
directly and materially advance the Federal Government's
substantial interest in reducing the number of children and
adolescents who use cigarettes and smokeless tobacco and in
preventing the life-threatening health consequences associated
with tobacco use. An overwhelming majority of Americans who use
tobacco products begin using such products while they are minors
and become addicted to the nicotine in those products before
reaching the age of 18. Tobacco advertising and promotion play a
crucial role in the decision of these minors to begin using
tobacco products. Less restrictive and less comprehensive
approaches have not and will not be effective in reducing the
problems addressed by such regulations. The reasonable
restrictions on the advertising and promotion of tobacco
products contained in such regulations will lead to a
significant decrease in the number of minors using and becoming
addicted to those products.
(32) The regulations described in paragraph (30) impose no
more extensive restrictions on communication by tobacco
manufacturers and sellers than are necessary to reduce the
number of children and adolescents who use cigarettes and
smokeless tobacco and to prevent the life-threatening health
consequences associated with tobacco use. Such regulations are
narrowly tailored to restrict those advertising and promotional
practices which are most likely to be seen or heard by youth and
most likely to entice them into tobacco use, while affording
tobacco manufacturers and sellers ample opportunity to convey
information about their products to adult consumers.
(33) Tobacco dependence is a chronic disease, one that
typically requires repeated interventions to achieve long-term
or permanent abstinence.
(34) Because the only known safe alternative to smoking is
cessation, interventions should target all smokers to help them
quit completely.
(35) Tobacco products have been used to facilitate and
finance criminal activities both domestically and
internationally. Illicit trade of tobacco products has been
linked to organized crime and terrorist groups.
(36) It is essential that the Food and Drug Administration
review products sold or distributed for use to reduce risks or
exposures associated with tobacco products and that it be
empowered to review any advertising and labeling for such
products. It is also essential that manufacturers, prior to
marketing such products, be required to demonstrate that such
products will meet a series of rigorous criteria, and will
benefit the health of the population as a whole, taking into
account both users of tobacco products and persons who do not
currently use tobacco products.
[[Page 123 STAT. 1780]]
(37) Unless tobacco products that purport to reduce the
risks to the public of tobacco use actually reduce such risks,
those products can cause substantial harm to the public health
to the extent that the individuals, who would otherwise not
consume tobacco products or would consume such products less,
use tobacco products purporting to reduce risk. Those who use
products sold or distributed as modified risk products that do
not in fact reduce risk, rather than quitting or reducing their
use of tobacco products, have a substantially increased
likelihood of suffering disability and premature death. The
costs to society of the widespread use of products sold or
distributed as modified risk products that do not in fact reduce
risk or that increase risk include thousands of unnecessary
deaths and injuries and huge costs to our health care system.
(38) As the National Cancer Institute has found, many
smokers mistakenly believe that ``low tar'' and ``light''
cigarettes cause fewer health problems than other cigarettes. As
the National Cancer Institute has also found, mistaken beliefs
about the health consequences of smoking ``low tar'' and
``light'' cigarettes can reduce the motivation to quit smoking
entirely and thereby lead to disease and death.
(39) Recent studies have demonstrated that there has been no
reduction in risk on a population-wide basis from ``low tar''
and ``light'' cigarettes, and such products may actually
increase the risk of tobacco use.
(40) The dangers of products sold or distributed as modified
risk tobacco products that do not in fact reduce risk are so
high that there is a compelling governmental interest in
ensuring that statements about modified risk tobacco products
are complete, accurate, and relate to the overall disease risk
of the product.
(41) As the Federal Trade Commission has found, consumers
have misinterpreted advertisements in which one product is
claimed to be less harmful than a comparable product, even in
the presence of disclosures and advisories intended to provide
clarification.
(42) Permitting manufacturers to make unsubstantiated
statements concerning modified risk tobacco products, whether
express or implied, even if accompanied by disclaimers would be
detrimental to the public health.
(43) The only way to effectively protect the public health
from the dangers of unsubstantiated modified risk tobacco
products is to empower the Food and Drug Administration to
require that products that tobacco manufacturers sold or
distributed for risk reduction be reviewed in advance of
marketing, and to require that the evidence relied on to support
claims be fully verified.
(44) The Food and Drug Administration is a regulatory agency
with the scientific expertise to identify harmful substances in
products to which consumers are exposed, to design standards to
limit exposure to those substances, to evaluate scientific
studies supporting claims about the safety of products, and to
evaluate the impact of labels, labeling, and advertising on
consumer behavior in order to reduce the risk of harm and
promote understanding of the impact of the product on health. In
connection with its mandate to promote health and reduce the
risk of harm, the Food and Drug Administration
[[Page 123 STAT. 1781]]
routinely makes decisions about whether and how products may be
marketed in the United States.
(45) The Federal Trade Commission was created to protect
consumers from unfair or deceptive acts or practices, and to
regulate unfair methods of competition. Its focus is on those
marketplace practices that deceive or mislead consumers, and
those that give some competitors an unfair advantage. Its
mission is to regulate activities in the marketplace. Neither
the Federal Trade Commission nor any other Federal agency except
the Food and Drug Administration possesses the scientific
expertise needed to implement effectively all provisions of the
Family Smoking Prevention and Tobacco Control Act.
(46) If manufacturers state or imply in communications
directed to consumers through the media or through a label,
labeling, or advertising, that a tobacco product is approved or
inspected by the Food and Drug Administration or complies with
Food and Drug Administration standards, consumers are likely to
be confused and misled. Depending upon the particular language
used and its context, such a statement could result in consumers
being misled into believing that the product is endorsed by the
Food and Drug Administration for use or in consumers being
misled about the harmfulness of the product because of such
regulation, inspection, approval, or compliance.
(47) In August 2006 a United States district court judge
found that the major United States cigarette companies continue
to target and market to youth. USA v. Philip Morris, USA, Inc.,
et al. (Civil Action No. 99-2496 (GK), August 17, 2006).
(48) In August 2006 a United States district court judge
found that the major United States cigarette companies
dramatically increased their advertising and promotional
spending in ways that encourage youth to start smoking
subsequent to the signing of the Master Settlement Agreement in
1998. USA v. Philip Morris, USA, Inc., et al. (Civil Action No.
99-2496 (GK), August 17, 2006).
(49) In August 2006 a United States district court judge
found that the major United States cigarette companies have
designed their cigarettes to precisely control nicotine delivery
levels and provide doses of nicotine sufficient to create and
sustain addiction while also concealing much of their nicotine-
related research. USA v. Philip Morris, USA, Inc., et al. (Civil
Action No. 99-2496 (GK), August 17, 2006).
SEC. 3. <<NOTE: 21 USC 387 note.>> PURPOSE.
The purposes of this division are--
(1) to provide authority to the Food and Drug Administration
to regulate tobacco products under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.), by recognizing it as the
primary Federal regulatory authority with respect to the
manufacture, marketing, and distribution of tobacco products as
provided for in this division;
(2) to ensure that the Food and Drug Administration has the
authority to address issues of particular concern to public
health officials, especially the use of tobacco by young people
and dependence on tobacco;
[[Page 123 STAT. 1782]]
(3) to authorize the Food and Drug Administration to set
national standards controlling the manufacture of tobacco
products and the identity, public disclosure, and amount of
ingredients used in such products;
(4) to provide new and flexible enforcement authority to
ensure that there is effective oversight of the tobacco
industry's efforts to develop, introduce, and promote less
harmful tobacco products;
(5) to vest the Food and Drug Administration with the
authority to regulate the levels of tar, nicotine, and other
harmful components of tobacco products;
(6) in order to ensure that consumers are better informed,
to require tobacco product manufacturers to disclose research
which has not previously been made available, as well as
research generated in the future, relating to the health and
dependency effects or safety of tobacco products;
(7) to continue to permit the sale of tobacco products to
adults in conjunction with measures to ensure that they are not
sold or accessible to underage purchasers;
(8) to impose appropriate regulatory controls on the tobacco
industry;
(9) to promote cessation to reduce disease risk and the
social costs associated with tobacco-related diseases; and
(10) to strengthen legislation against illicit trade in
tobacco products.
SEC. 4. <<NOTE: 21 USC 387 note.>> SCOPE AND EFFECT.
(a) Intended Effect.--Nothing in this division (or an amendment made
by this division) shall be construed to--
(1) establish a precedent with regard to any other industry,
situation, circumstance, or legal action; or
(2) affect any action pending in Federal, State, or tribal
court, or any agreement, consent decree, or contract of any
kind.
(b) Agricultural Activities.--The provisions of this division (or an
amendment made by this division) which authorize the Secretary to take
certain actions with regard to tobacco and tobacco products shall not be
construed to affect any authority of the Secretary of Agriculture under
existing law regarding the growing, cultivation, or curing of raw
tobacco.
(c) Revenue Activities.--The provisions of this division (or an
amendment made by this division) which authorize the Secretary to take
certain actions with regard to tobacco products shall not be construed
to affect any authority of the Secretary of the Treasury under chapter
52 of the Internal Revenue Code of 1986.
SEC. 5. <<NOTE: 21 USC 387 note.>> SEVERABILITY.
If any provision of this division, of the amendments made by this
division, or of the regulations promulgated under this division (or
under such amendments), or the application of any such provision to any
person or circumstance is held to be invalid, the remainder of this
division, such amendments and such regulations, and the application of
such provisions to any other person or circumstance shall not be
affected and shall continue to be enforced to the fullest extent
possible.
[[Page 123 STAT. 1783]]
SEC. 6. MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION.
(a) Delayed Commencement of Dates for Secretarial Action.--
(1) In general.--Except as provided in subsection (c), with
respect to any time periods specified in this division (or in an
amendment made by this division) that begin on the date of
enactment of this Act, within which the Secretary of Health and
Human Services is required to carry out and complete specified
activities, the calculation of such time periods shall commence
on the date described in subsection (b).
(2) <<NOTE: Applicability.>> Limitation.--Subsection (a)
shall only apply with respect to obligations of the Secretary of
Health and Human Services that must be completed within a
specified time period and shall not apply to the obligations of
any other person or to any other provision of this division
(including the amendments made by this division) that do not
create such obligations of the Secretary and are not contingent
on actions by the Secretary.
(b) Date Described.--The date described in this subsection is the
first day of the first fiscal quarter following the initial 2
consecutive fiscal quarters of fiscal year 2010 for which the Secretary
of Health and Human Services has collected fees under section 919 of the
Federal Food, Drug, and Cosmetic Act (as added by section 101).
(c) Exception.--Subsection (a) shall not apply to any time period
(or date) contained--
(1) in section 102, except that the reference to ``180
days'' in subsection (a)(1) of such section shall be deemed to
be ``270 days''; and
(2) in sections 201 through 204 (or the amendments made by
any such sections).
(d) Adjustment.--The Secretary of Health and Human Services may
extend or reduce the duration of one or more time periods to which
subsection (a) applies if the Secretary determines appropriate, except
that no such period shall be extended for more than 90 days.
TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) Definition of Tobacco Products.--Section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the
end the following:
``(rr)(1) The term `tobacco product' means any product made or
derived from tobacco that is intended for human consumption, including
any component, part, or accessory of a tobacco product (except for raw
materials other than tobacco used in manufacturing a component, part, or
accessory of a tobacco product).
``(2) The term `tobacco product' does not mean an article that is a
drug under subsection (g)(1), a device under subsection (h), or a
combination product described in section 503(g).
``(3) The products described in paragraph (2) shall be subject to
chapter V of this Act.
[[Page 123 STAT. 1784]]
``(4) A tobacco product shall not be marketed in combination with
any other article or product regulated under this Act (including a drug,
biologic, food, cosmetic, medical device, or a dietary supplement).''.
(b) FDA Authority Over Tobacco Products.--The Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
(1) by redesignating chapter IX <<NOTE: 21 USC 3913et
seq. 21 USC 391, 301 note, 392 and note, 393-399a.>> as chapter
X;
(2) by redesignating sections 901 through 910 as sections
1001 through 1010; and
(3) by inserting after chapter VIII the following:
``CHAPTER IX--TOBACCO PRODUCTS
``SEC. 900. <<NOTE: 21 USC 387.>> DEFINITIONS.
``In this chapter:
``(1) Additive.--The term `additive' means any substance the
intended use of which results or may reasonably be expected to
result, directly or indirectly, in its becoming a component or
otherwise affecting the characteristic of any tobacco product
(including any substances intended for use as a flavoring or
coloring or in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding),
except that such term does not include tobacco or a pesticide
chemical residue in or on raw tobacco or a pesticide chemical.
``(2) Brand.--The term `brand' means a variety of tobacco
product distinguished by the tobacco used, tar content, nicotine
content, flavoring used, size, filtration, packaging, logo,
registered trademark, brand name, identifiable pattern of
colors, or any combination of such attributes.
``(3) Cigarette.--The term `cigarette'--
``(A) means a product that--
``(i) is a tobacco product; and
``(ii) meets the definition of the term
`cigarette' in section 3(1) of the Federal
Cigarette Labeling and Advertising Act; and
``(B) includes tobacco, in any form, that is
functional in the product, which, because of its
appearance, the type of tobacco used in the filler, or
its packaging and labeling, is likely to be offered to,
or purchased by, consumers as a cigarette or as roll-
your-own tobacco.
``(4) Cigarette tobacco.--The term `cigarette tobacco' means
any product that consists of loose tobacco that is intended for
use by consumers in a cigarette. Unless otherwise stated, the
requirements applicable to cigarettes under this chapter shall
also apply to cigarette tobacco.
``(5) Commerce.--The term `commerce' has the meaning given
that term by section 3(2) of the Federal Cigarette Labeling and
Advertising Act.
``(6) Counterfeit tobacco product.--The term `counterfeit
tobacco product' means a tobacco product (or the container or
labeling of such a product) that, without authorization, bears
the trademark, trade name, or other identifying mark, imprint,
or device, or any likeness thereof, of a tobacco product listed
in a registration under section 905(i)(1).
``(7) Distributor.--The term `distributor' as regards a
tobacco product means any person who furthers the distribution
of a tobacco product, whether domestic or imported, at any
[[Page 123 STAT. 1785]]
point from the original place of manufacture to the person who
sells or distributes the product to individuals for personal
consumption. Common carriers are not considered distributors for
purposes of this chapter.
``(8) Illicit trade.--The term `illicit trade' means any
practice or conduct prohibited by law which relates to
production, shipment, receipt, possession, distribution, sale,
or purchase of tobacco products including any practice or
conduct intended to facilitate such activity.
``(9) Indian country.--The term `Indian country' has the
meaning given such term in section 1151 of title 18, United
States Code.
``(10) Indian tribe.--The term `Indian tribe' has the
meaning given such term in section 4(e) of the Indian Self-
Determination and Education Assistance Act.
``(11) Little cigar.--The term `little cigar' means a
product that--
``(A) is a tobacco product; and
``(B) meets the definition of the term `little
cigar' in section 3(7) of the Federal Cigarette Labeling
and Advertising Act.
``(12) Nicotine.--The term `nicotine' means the chemical
substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or
C[10]H[14]N[2], including any salt or complex of nicotine.
``(13) Package.--The term `package' means a pack, box,
carton, or container of any kind or, if no other container, any
wrapping (including cellophane), in which a tobacco product is
offered for sale, sold, or otherwise distributed to consumers.
``(14) Retailer.--The term `retailer' means any person,
government, or entity who sells tobacco products to individuals
for personal consumption, or who operates a facility where self-
service displays of tobacco products are permitted.
``(15) Roll-your-own tobacco.--The term `roll-your-own
tobacco' means any tobacco product which, because of its
appearance, type, packaging, or labeling, is suitable for use
and likely to be offered to, or purchased by, consumers as
tobacco for making cigarettes.
``(16) Small tobacco product manufacturer.--The term `small
tobacco product manufacturer' means a tobacco product
manufacturer that employs fewer than 350 employees. For purposes
of determining the number of employees of a manufacturer under
the preceding sentence, the employees of a manufacturer are
deemed to include the employees of each entity that controls, is
controlled by, or is under common control with such
manufacturer.
``(17) Smoke constituent.--The term `smoke constituent'
means any chemical or chemical compound in mainstream or
sidestream tobacco smoke that either transfers from any
component of the cigarette to the smoke or that is formed by the
combustion or heating of tobacco, additives, or other component
of the tobacco product.
``(18) Smokeless tobacco.--The term `smokeless tobacco'
means any tobacco product that consists of cut, ground,
powdered, or leaf tobacco and that is intended to be placed in
the oral or nasal cavity.
``(19) State; territory.--The terms `State' and `Territory'
shall have the meanings given to such terms in section 201.
[[Page 123 STAT. 1786]]
``(20) Tobacco product manufacturer.--The term `tobacco
product manufacturer' means any person, including any repacker
or relabeler, who--
``(A) manufactures, fabricates, assembles,
processes, or labels a tobacco product; or
``(B) imports a finished tobacco product for sale or
distribution in the United States.
``(21) Tobacco warehouse.--
``(A) Subject to subparagraphs (B) and (C), the term
`tobacco warehouse' includes any person--
``(i) who--
``(I) removes foreign material from
tobacco leaf through nothing other than
a mechanical process;
``(II) humidifies tobacco leaf with
nothing other than potable water in the
form of steam or mist; or
``(III) de-stems, dries, and packs
tobacco leaf for storage and shipment;
``(ii) who performs no other actions with
respect to tobacco leaf; and
``(iii) who provides to any manufacturer to
whom the person sells tobacco all information
related to the person's actions described in
clause (i) that is necessary for compliance with
this Act.
``(B) The term `tobacco warehouse' excludes any
person who--
``(i) reconstitutes tobacco leaf;
``(ii) is a manufacturer, distributor, or
retailer of a tobacco product; or
``(iii) applies any chemical, additive, or
substance to the tobacco leaf other than potable
water in the form of steam or mist.
``(C) The definition of the term `tobacco warehouse'
in subparagraph (A) shall not apply to the extent to
which the Secretary determines, through rulemaking, that
regulation under this chapter of the actions described
in such subparagraph is appropriate for the protection
of the public health.
``(22) United states.--The term `United States' means the 50
States of the United States of America and the District of
Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin
Islands, American Samoa, Wake Island, Midway Islands, Kingman
Reef, Johnston Atoll, the Northern Mariana Islands, and any
other trust territory or possession of the United States.
``SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.
``(a) In General.--Tobacco <<NOTE: Regulations. 21 USC 387a.>>
products, including modified risk tobacco products for which an order
has been issued in accordance with section 911, shall be regulated by
the Secretary under this chapter and shall not be subject to the
provisions of chapter V.
``(b) Applicability.--This chapter shall apply to all cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to
any other tobacco products that the Secretary by regulation deems to be
subject to this chapter.
``(c) Scope.--
``(1) In general.--Nothing in this chapter, or any policy
issued or regulation promulgated thereunder, or in sections
[[Page 123 STAT. 1787]]
101(a), 102, or 103 of title I, title II, or title III of the
Family Smoking Prevention and Tobacco Control Act, shall be
construed to affect, expand, or limit the Secretary's authority
over (including the authority to determine whether products may
be regulated), or the regulation of, products under this Act
that are not tobacco products under chapter V or any other
chapter.
``(2) Limitation of authority.--
``(A) In general.--The provisions of this chapter
shall not apply to tobacco leaf that is not in the
possession of a manufacturer of tobacco products, or to
the producers of tobacco leaf, including tobacco
growers, tobacco warehouses, and tobacco grower
cooperatives, nor shall any employee of the Food and
Drug Administration have any authority to enter onto a
farm owned by a producer of tobacco leaf without the
written consent of such producer.
``(B) Exception.--Notwithstanding subparagraph (A),
if a producer of tobacco leaf is also a tobacco product
manufacturer or controlled by a tobacco product
manufacturer, the producer shall be subject to this
chapter in the producer's capacity as a manufacturer.
The exception in this subparagraph shall not apply to a
producer of tobacco leaf who grows tobacco under a
contract with a tobacco product manufacturer and who is
not otherwise engaged in the manufacturing process.
``(C) Rule of construction.--Nothing in this chapter
shall be construed to grant the Secretary authority to
promulgate regulations on any matter that involves the
production of tobacco leaf or a producer thereof, other
than activities by a manufacturer affecting production.
``(d) Rulemaking Procedures.--Each rulemaking under this chapter
shall be in accordance with chapter 5 of title 5, United States Code.
This subsection shall not be construed to affect the rulemaking
provisions of section 102(a) of the Family Smoking Prevention and
Tobacco Control Act.
``(e) Center for Tobacco Products.--Not
later <<NOTE: Deadline. Establishment.>> than 90 days after the date of
enactment of the Family Smoking Prevention and Tobacco Control Act, the
Secretary shall establish within the Food and Drug Administration the
Center for Tobacco Products, which shall report to the Commissioner of
Food and Drugs in the same manner as the other agency centers within the
Food and Drug Administration. The Center shall be responsible for the
implementation of this chapter and related matters assigned by the
Commissioner.
``(f) Office To Assist Small Tobacco Product Manufacturers.--The
Secretary <<NOTE: Establishment.>> shall establish within the Food and
Drug Administration an identifiable office to provide technical and
other nonfinancial assistance to small tobacco product manufacturers to
assist them in complying with the requirements of this Act.
``(g) Consultation Prior to Rulemaking.--Prior to promulgating rules
under this chapter, the Secretary shall endeavor to consult with other
Federal agencies as appropriate.
``SEC. 902. <<NOTE: 21 USC 387b.>> ADULTERATED TOBACCO PRODUCTS.
``A tobacco product shall be deemed to be adulterated if--
``(1) it consists in whole or in part of any filthy, putrid,
or decomposed substance, or is otherwise contaminated by any
[[Page 123 STAT. 1788]]
added poisonous or added deleterious substance that may render
the product injurious to health;
``(2) it has been prepared, packed, or held under insanitary
conditions whereby it may have been contaminated with filth, or
whereby it may have been rendered injurious to health;
``(3) its package is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health;
``(4) the manufacturer or importer of the tobacco product
fails to pay a user fee assessed to such manufacturer or
importer pursuant to section 919 by the date specified in
section 919 or by the 30th day after final agency action on a
resolution of any dispute as to the amount of such fee;
``(5) it is, or purports to be or is represented as, a
tobacco product which is subject to a tobacco product standard
established under section 907 unless such tobacco product is in
all respects in conformity with such standard;
``(6)(A) it is required by section 910(a) to have premarket
review and does not have an order in effect under section
910(c)(1)(A)(i); or
``(B) it is in violation of an order under section
910(c)(1)(A);
``(7) the methods used in, or the facilities or controls
used for, its manufacture, packing, or storage are not in
conformity with applicable requirements under section 906(e)(1)
or an applicable condition prescribed by an order under section
906(e)(2); or
``(8) it is in violation of section 911.
``SEC. 903. <<NOTE: Labeling. 21 USC 387c.>> MISBRANDED TOBACCO
PRODUCTS.
``(a) In General.--A tobacco product shall be deemed to be
misbranded--
``(1) if its labeling is false or misleading in any
particular;
``(2) if in package form unless it bears a label
containing--
``(A) the name and place of business of the tobacco
product manufacturer, packer, or distributor;
``(B) an accurate statement of the quantity of the
contents in terms of weight, measure, or numerical
count;
``(C) an accurate statement of the percentage of the
tobacco used in the product that is domestically grown
tobacco and the percentage that is foreign grown
tobacco; and
``(D) the <<NOTE: Regulations.>> statement required
under section 920(a),
except that under subparagraph (B) reasonable variations shall
be permitted, and exemptions as to small packages shall be
established, by regulations prescribed by the Secretary;
``(3) if any word, statement, or other information required
by or under authority of this chapter to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements, or
designs in the labeling) and in such terms as to render it
likely to be read and understood by the ordinary individual
under customary conditions of purchase and use;
``(4) if it has an established name, unless its label bears,
to the exclusion of any other nonproprietary name, its
established name prominently printed in type as required by the
Secretary by regulation;
[[Page 123 STAT. 1789]]
``(5) if the Secretary has issued regulations requiring that
its labeling bear adequate directions for use, or adequate
warnings against use by children, that are necessary for the
protection of users unless its labeling conforms in all respects
to such regulations;
``(6) if it was manufactured, prepared, propagated,
compounded, or processed in an establishment not duly registered
under section 905(b), 905(c), 905(d), or 905(h), if it was not
included in a list required by section 905(i), if a notice or
other information respecting it was not provided as required by
such section or section 905(j), or if it does not bear such
symbols from the uniform system for identification of tobacco
products prescribed under section 905(e) as the Secretary by
regulation requires;
``(7) if, in the case of any tobacco product distributed or
offered for sale in any State--
``(A) its advertising is false or misleading in any
particular; or
``(B) it is sold or distributed in violation of
regulations prescribed under section 906(d);
``(8) unless, in the case of any tobacco product distributed
or offered for sale in any State, the manufacturer, packer, or
distributor thereof includes in all advertisements and other
descriptive printed matter issued or caused to be issued by the
manufacturer, packer, or distributor with respect to that
tobacco product--
``(A) a true statement of the tobacco product's
established name as described in paragraph (4), printed
prominently; and
``(B) a brief statement of--
``(i) the uses of the tobacco product and
relevant warnings, precautions, side effects, and
contraindications; and
``(ii) in <<NOTE: Regulations. Hearings.>>
the case of specific tobacco products made subject
to a finding by the Secretary after notice and
opportunity for comment that such action is
appropriate to protect the public health, a full
description of the components of such tobacco
product or the formula showing quantitatively each
ingredient of such tobacco product to the extent
required in regulations which shall be issued by
the Secretary after an opportunity for a hearing;
``(9) if it is a tobacco product subject to a tobacco
product standard established under section 907, unless it bears
such labeling as may be prescribed in such tobacco product
standard; or
``(10) if there was a failure or refusal--
``(A) to comply with any requirement prescribed
under section 904 or 908; or
``(B) to furnish any material or information
required under section 909.
``(b) Prior Approval of Label Statements.--The Secretary may, by
regulation, require prior approval of statements made on the label of a
tobacco product to ensure that such statements do not violate the
misbranding provisions of subsection (a) and that such statements comply
with other provisions of the Family
[[Page 123 STAT. 1790]]
Smoking Prevention and Tobacco Control Act (including the amendments
made by such Act). No regulation issued under this subsection may
require prior approval by the Secretary of the content of any
advertisement, except for modified risk tobacco products as provided in
section 911. No advertisement of a tobacco product published after the
date of enactment of the Family Smoking Prevention and Tobacco Control
Act shall, with respect to the language of label statements as
prescribed under section 4 of the Federal Cigarette Labeling and
Advertising Act and section 3 of the Comprehensive Smokeless Tobacco
Health Education Act of 1986 or the regulations issued under such
sections, be subject to the provisions of sections 12 through 15 of the
Federal Trade Commission Act.
``SEC. 904. <<NOTE: 21 USC 387d.>> SUBMISSION OF HEALTH
INFORMATION TO THE SECRETARY.
``(a) Requirement.--Each tobacco product manufacturer or importer,
or agents thereof, shall submit to the Secretary the following
information:
``(1) Not <<NOTE: Deadline.>> later than 6 months after the
date of enactment of the Family Smoking Prevention and Tobacco
Control Act, a listing of all ingredients, including tobacco,
substances, compounds, and additives that are, as of such date,
added by the manufacturer to the tobacco, paper, filter, or
other part of each tobacco product by brand and by quantity in
each brand and subbrand.
``(2) A description of the content, delivery, and form of
nicotine in each tobacco product measured in milligrams of
nicotine in accordance with regulations promulgated by the
Secretary in accordance with section 4(e) of the Federal
Cigarette Labeling and Advertising Act.
``(3) Beginning <<NOTE: Effective date.>> 3 years after the
date of enactment of the Family Smoking Prevention and Tobacco
Control Act, a listing of all constituents, including smoke
constituents as applicable, identified by the Secretary as
harmful or potentially harmful to health in each tobacco
product, and as applicable in the smoke of each tobacco product,
by brand and by quantity in each brand and subbrand. Effective
beginning 3 years after such date of enactment, the
manufacturer, importer, or agent shall comply with regulations
promulgated under section 915 in reporting information under
this paragraph, where applicable.
``(4) Beginning <<NOTE: Effective date.>> 6 months after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, all documents developed after such date of
enactment that relate to health, toxicological, behavioral, or
physiologic effects of current or future tobacco products, their
constituents (including smoke constituents), ingredients,
components, and additives.
``(b) Data Submission.--At the request of the Secretary, each
tobacco product manufacturer or importer of tobacco products, or agents
thereof, shall submit the following:
``(1) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the manufacturer
(or agents thereof) on the health, toxicological, behavioral, or
physiologic effects of tobacco products and their constituents
[[Page 123 STAT. 1791]]
(including smoke constituents), ingredients, components, and
additives.
``(2) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the manufacturer
(or agents thereof) that relate to the issue of whether a
reduction in risk to health from tobacco products can occur upon
the employment of technology available or known to the
manufacturer.
``(3) Any or all documents (including underlying scientific
or financial information) relating to marketing research
involving the use of tobacco products or marketing practices and
the effectiveness of such practices used by tobacco
manufacturers and distributors.
An importer of a tobacco product not manufactured in the United States
shall supply the information required of a tobacco product manufacturer
under this subsection.
``(c) Time for Submission.--
``(1) In general.--At least 90 days prior to the delivery
for introduction into interstate commerce of a tobacco product
not on the market on the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, the manufacturer of such
product shall provide the information required under subsection
(a).
``(2) Disclosure of additive.--If at any time a tobacco
product manufacturer adds to its tobacco products a new tobacco
additive or increases the quantity of an existing tobacco
additive, the manufacturer shall, except as provided in
paragraph (3), at least 90 days prior to such action so advise
the Secretary in writing.
``(3) Disclosure of other actions.--If at any time a tobacco
product manufacturer eliminates or decreases an existing
additive, or adds or increases an additive that has by
regulation been designated by the Secretary as an additive that
is not a human or animal carcinogen, or otherwise harmful to
health under intended conditions of use, the manufacturer shall
within 60 days of such action so advise the Secretary in
writing.
``(d) Data List.--
``(1) In general.--Not
later <<NOTE: Deadlines. Publication. Public information.>>
than 3 years after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, and annually thereafter, the
Secretary shall publish in a format that is understandable and
not misleading to a lay person, and place on public display (in
a manner determined by the Secretary) the list established under
subsection (e).
``(2) Consumer research.--The Secretary shall conduct
periodic consumer research to ensure that the list published
under paragraph (1) is not misleading to lay
persons. <<NOTE: Deadline. Reports. Recommenda- tions.>> Not
later than 5 years after the date of enactment of the Family
Smoking Prevention and Tobacco Control Act, the Secretary shall
submit to the appropriate committees of Congress a report on the
results of such research, together with recommendations on
whether such publication should be continued or modified.
``(e) Data Collection.--Not later <<NOTE: Deadline.>> than 24
months after the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall establish, and periodically
revise
[[Page 123 STAT. 1792]]
as appropriate, a list of harmful and potentially harmful constituents,
including smoke constituents, to health in each tobacco product by brand
and by quantity in each brand and
subbrand. <<NOTE: Publication. Notice.>> The Secretary shall publish a
public notice requesting the submission by interested persons of
scientific and other information concerning the harmful and potentially
harmful constituents in tobacco products and tobacco smoke.
``SEC. 905. <<NOTE: 21 USC 387e.>> ANNUAL REGISTRATION.
``(a) Definitions.--In this section:
``(1) Manufacture, preparation, compounding, or
processing.--The term `manufacture, preparation, compounding, or
processing' shall include repackaging or otherwise changing the
container, wrapper, or labeling of any tobacco product package
in furtherance of the distribution of the tobacco product from
the original place of manufacture to the person who makes final
delivery or sale to the ultimate consumer or user.
``(2) Name.--The term `name' shall include in the case of a
partnership the name of each partner and, in the case of a
corporation, the name of each corporate officer and director,
and the State of incorporation.
``(b) Registration by Owners and Operators.--On or before December
31 of each year, every person who owns or operates any establishment in
any State engaged in the manufacture, preparation, compounding, or
processing of a tobacco product or tobacco products shall register with
the Secretary the name, places of business, and all such establishments
of that person. <<NOTE: Deadline.>> If enactment of the Family Smoking
Prevention and Tobacco Control Act occurs in the second half of the
calendar year, the Secretary shall designate a date no later than 6
months into the subsequent calendar year by which registration pursuant
to this subsection shall occur.
``(c) Registration by New Owners and Operators.--Every person upon
first engaging in the manufacture, preparation, compounding, or
processing of a tobacco product or tobacco products in any establishment
owned or operated in any State by that person shall immediately register
with the Secretary that person's name, place of business, and such
establishment.
``(d) Registration of Added Establishments.--Every person required
to register under subsection (b) or (c) shall immediately register with
the Secretary any additional establishment which that person owns or
operates in any State and in which that person begins the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products.
``(e) Uniform Product Identification System.--The Secretary may by
regulation prescribe a uniform system for the identification of tobacco
products and may require that persons who are required to list such
tobacco products under subsection (i) shall list such tobacco products
in accordance with such system.
``(f) Public Access to Registration Information.--The Secretary
shall make available for inspection, to any person so requesting, any
registration filed under this section.
``(g) Biennial Inspection of Registered Establishments.--Every
establishment registered with the Secretary under this section shall be
subject to inspection under section 704 or subsection (h), and every
such establishment engaged in the manufacture, compounding, or
processing of a tobacco product or tobacco products shall be so
inspected by 1 or more officers or employees duly
[[Page 123 STAT. 1793]]
designated by the Secretary at least once in the 2-year period beginning
with the date of registration of such establishment under this section
and at least once in every successive 2-year period thereafter.
``(h) <<NOTE: Regulations.>> Registration by Foreign
Establishments.--Any establishment within any foreign country engaged in
the manufacture, preparation, compounding, or processing of a tobacco
product or tobacco products, shall register under this section under
regulations promulgated by the Secretary. Such regulations shall require
such establishment to provide the information required by subsection (i)
and shall include provisions for registration of any such establishment
upon condition that adequate and effective means are available, by
arrangement with the government of such foreign country or otherwise, to
enable the Secretary to determine from time to time whether tobacco
products manufactured, prepared, compounded, or processed in such
establishment, if imported or offered for import into the United States,
shall be refused admission on any of the grounds set forth in section
801(a).
``(i) Registration Information.--
``(1) Product list.--Every person who registers with the
Secretary under subsection (b), (c), (d), or (h) shall, at the
time of registration under any such subsection, file with the
Secretary a list of all tobacco products which are being
manufactured, prepared, compounded, or processed by that person
for commercial distribution and which have not been included in
any list of tobacco products filed by that person with the
Secretary under this paragraph or paragraph (2) before such time
of registration. Such list shall be prepared in such form and
manner as the Secretary may prescribe and shall be accompanied
by--
``(A) in the case of a tobacco product contained in
the applicable list with respect to which a tobacco
product standard has been established under section 907
or which is subject to section 910, a reference to the
authority for the marketing of such tobacco product and
a copy of all labeling for such tobacco product;
``(B) in the case of any other tobacco product
contained in an applicable list, a copy of all consumer
information and other labeling for such tobacco product,
a representative sampling of advertisements for such
tobacco product, and, upon request made by the Secretary
for good cause, a copy of all advertisements for a
particular tobacco product; and
``(C) if the registrant filing a list has determined
that a tobacco product contained in such list is not
subject to a tobacco product standard established under
section 907, a brief statement of the basis upon which
the registrant made such determination if the Secretary
requests such a statement with respect to that
particular tobacco product.
``(2) Consultation with respect to forms.--The Secretary
shall consult with the Secretary of the Treasury in developing
the forms to be used for registration under this section to
minimize the burden on those persons required to register with
both the Secretary and the Tax and Trade Bureau of the
Department of the Treasury.
[[Page 123 STAT. 1794]]
``(3) Biannual report of any change in product list.--Each
person who registers with the Secretary under this section shall
report to the Secretary once during the month of June of each
year and once during the month of December of each year the
following:
``(A) A list of each tobacco product introduced by
the registrant for commercial distribution which has not
been included in any list previously filed by that
person with the Secretary under this subparagraph or
paragraph (1). A list under this subparagraph shall list
a tobacco product by its established name and shall be
accompanied by the other information required by
paragraph (1).
``(B) If <<NOTE: Notice.>> since the date the
registrant last made a report under this paragraph that
person has discontinued the manufacture, preparation,
compounding, or processing for commercial distribution
of a tobacco product included in a list filed under
subparagraph (A) or paragraph (1), notice of such
discontinuance, the date of such discontinuance, and the
identity of its established name.
``(C) If <<NOTE: Notice.>> since the date the
registrant reported under subparagraph (B) a notice of
discontinuance that person has resumed the manufacture,
preparation, compounding, or processing for commercial
distribution of the tobacco product with respect to
which such notice of discontinuance was reported, notice
of such resumption, the date of such resumption, the
identity of such tobacco product by established name,
and other information required by paragraph (1), unless
the registrant has previously reported such resumption
to the Secretary under this subparagraph.
``(D) Any material change in any information
previously submitted under this paragraph or paragraph
(1).
``(j) Report Preceding Introduction of Certain Substantially
Equivalent Products Into Interstate Commerce.--
``(1) In general.--Each person who is required to register
under this section and who proposes to begin the introduction or
delivery for introduction into interstate commerce for
commercial distribution of a tobacco product intended for human
use that was not commercially marketed (other than for test
marketing) in the United States as of February 15, 2007, shall,
at least 90 days prior to making such introduction or delivery,
report to the Secretary (in such form and manner as the
Secretary shall prescribe)--
``(A) the basis for such person's determination
that--
``(i) the tobacco product is substantially
equivalent, within the meaning of section 910, to
a tobacco product commercially marketed (other
than for test marketing) in the United States as
of February 15, 2007, or to a tobacco product that
the Secretary has previously determined, pursuant
to subsection (a)(3) of section 910, is
substantially equivalent and that is in compliance
with the requirements of this Act; or
``(ii) the tobacco product is modified within
the meaning of paragraph (3), the modifications
are to a product that is commercially marketed and
in compliance with the requirements of this Act,
and all of the modifications are covered by
exemptions granted by the Secretary pursuant to
paragraph (3); and
[[Page 123 STAT. 1795]]
``(B) action taken by such person to comply with the
requirements under section 907 that are applicable to
the tobacco product.
``(2) Application to certain post-february 15, 2007,
products.--A report under this subsection for a tobacco product
that was first introduced or delivered for introduction into
interstate commerce for commercial distribution in the United
States after February 15, 2007, and prior to the date that is 21
months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act shall be submitted to the
Secretary not later than 21 months after such date of enactment.
``(3) Exemptions.--
``(A) In general.--The Secretary may exempt from the
requirements of this subsection relating to the
demonstration that a tobacco product is substantially
equivalent within the meaning of section 910, tobacco
products that are modified by adding or deleting a
tobacco additive, or increasing or decreasing the
quantity of an existing tobacco additive, if the
Secretary determines that--
``(i) such modification would be a minor
modification of a tobacco product that can be sold
under this Act;
``(ii) a report under this subsection is not
necessary to ensure that permitting the tobacco
product to be marketed would be appropriate for
protection of the public health; and
``(iii) an exemption is otherwise appropriate.
``(B) Regulations.--Not later <<NOTE: Deadline.>>
than 15 months after the date of enactment of the Family
Smoking Prevention and Tobacco Control Act, the
Secretary shall issue regulations to implement this
paragraph.
``SEC. 906. <<NOTE: 21 USC 387f.>> GENERAL PROVISIONS RESPECTING
CONTROL OF TOBACCO PRODUCTS.
``(a) In General.--Any requirement <<NOTE: Applicability.>>
established by or under section 902, 903, 905, or 909 applicable to a
tobacco product shall apply to such tobacco product until the
applicability of the requirement to the tobacco product has been changed
by action taken under section 907, section 910, section 911, or
subsection (d) of this section, and any requirement established by or
under section 902, 903, 905, or 909 which is inconsistent with a
requirement imposed on such tobacco product under section 907, section
910, section 911, or subsection (d) of this section shall not apply to
such tobacco product.
``(b) <<NOTE: Notice. Federal Register, publication.>> Information
on Public Access and Comment.--Each notice of proposed rulemaking or
other notification under section 907, 908, 909, 910, or 911 or under
this section, any other notice which is published in the Federal
Register with respect to any other action taken under any such section
and which states the reasons for such action, and each publication of
findings required to be made in connection with rulemaking under any
such section shall set forth--
``(1) the manner in which interested persons may examine
data and other information on which the notice or findings is
based; and
[[Page 123 STAT. 1796]]
``(2) the <<NOTE: Time period.>> period within which
interested persons may present their comments on the notice or
findings (including the need therefore) orally or in writing,
which period shall be at least 60 days but may not exceed 90
days unless the time is extended by the Secretary by a notice
published in the Federal Register stating good cause therefore.
``(c) Limited Confidentiality of Information.--Any information
reported to or otherwise obtained by the Secretary or the Secretary's
representative under section 903, 904, 907, 908, 909, 910, 911, or 704,
or under subsection (e) or (f) of this section, which is exempt from
disclosure under subsection (a) of section 552 of title 5, United States
Code, by reason of subsection (b)(4) of that section shall be considered
confidential and shall not be disclosed, except that the information may
be disclosed to other officers or employees concerned with carrying out
this chapter, or when relevant in any proceeding under this chapter.
``(d) Restrictions.--
``(1) In general.--The Secretary may by regulation require
restrictions on the sale and distribution of a tobacco product,
including restrictions on the access to, and the advertising and
promotion of, the tobacco product, if the Secretary determines
that such regulation would be appropriate for the protection of
the public health. The Secretary may by regulation impose
restrictions on the advertising and promotion of a tobacco
product consistent with and to full extent permitted by the
first amendment to the Constitution. The finding as to whether
such regulation would be appropriate for the protection of the
public health shall be determined with respect to the risks and
benefits to the population as a whole, including users and
nonusers of the tobacco product, and taking into account--
``(A) the increased or decreased likelihood that
existing users of tobacco products will stop using such
products; and
``(B) the increased or decreased likelihood that
those who do not use tobacco products will start using
such products.
No such regulation may require that the sale or distribution of
a tobacco product be limited to the written or oral
authorization of a practitioner licensed by law to prescribe
medical products.
``(2) Label statements.--The label of a tobacco product
shall bear such appropriate statements of the restrictions
required by a regulation under subsection (a) as the Secretary
may in such regulation prescribe.
``(3) Limitations.--
``(A) In general.--No restrictions under paragraph
(1) may--
``(i) prohibit the sale of any tobacco product
in face-to-face transactions by a specific
category of retail outlets; or
``(ii) establish a minimum age of sale of
tobacco products to any person older than 18 years
of age.
``(B) Matchbooks.--For purposes of any regulations
issued by the Secretary, matchbooks of conventional size
containing not more than 20 paper matches, and which are
customarily given away for free with the purchase
[[Page 123 STAT. 1797]]
of tobacco products, shall be considered as adult-
written publications which shall be permitted to contain
advertising. Notwithstanding the preceding sentence, if
the Secretary finds that such treatment of matchbooks is
not appropriate for the protection of the public health,
the Secretary may determine by regulation that
matchbooks shall not be considered adult-written
publications.
``(4) Remote sales.--
``(A) <<NOTE: Deadlines. Regulations.>> In
general.--The Secretary shall--
``(i) within 18 months after the date of
enactment of the Family Smoking Prevention and
Tobacco Control Act, promulgate regulations
regarding the sale and distribution of tobacco
products that occur through means other than a
direct, face-to-face exchange between a retailer
and a consumer in order to prevent the sale and
distribution of tobacco products to individuals
who have not attained the minimum age established
by applicable law for the purchase of such
products, including requirements for age
verification; and
``(ii) within 2 years after such date of
enactment, issue regulations to address the
promotion and marketing of tobacco products that
are sold or distributed through means other than a
direct, face-to-face exchange between a retailer
and a consumer in order to protect individuals who
have not attained the minimum age established by
applicable law for the purchase of such products.
``(B) Relation to other authority.--Nothing in this
paragraph limits the authority of the Secretary to take
additional actions under the other paragraphs of this
subsection.
``(e) Good Manufacturing Practice Requirements.--
``(1) Methods, facilities, and controls to conform.--
``(A) <<NOTE: Regulations.>> In general.--In
applying manufacturing restrictions to tobacco, the
Secretary shall, in accordance with subparagraph (B),
prescribe regulations (which may differ based on the
type of tobacco product involved) requiring that the
methods used in, and the facilities and controls used
for, the manufacture, preproduction design validation
(including a process to assess the performance of a
tobacco product), packing, and storage of a tobacco
product conform to current good manufacturing practice,
or hazard analysis and critical control point
methodology, as prescribed in such regulations to assure
that the public health is protected and that the tobacco
product is in compliance with this chapter. Such
regulations may provide for the testing of raw tobacco
for pesticide chemical residues regardless of whether a
tolerance for such chemical residues has been
established.
``(B) Requirements.--The Secretary shall--
``(i) <<NOTE: Recommenda- tions.>> before
promulgating any regulation under subparagraph
(A), afford the Tobacco Products Scientific
Advisory Committee an opportunity to submit
recommendations with respect to the regulation
proposed to be promulgated;
[[Page 123 STAT. 1798]]
``(ii) before <<NOTE: Hearings.>>
promulgating any regulation under subparagraph
(A), afford opportunity for an oral hearing;
``(iii) provide the Tobacco Products
Scientific Advisory Committee a reasonable time to
make its recommendation with respect to proposed
regulations under subparagraph (A);
``(iv) in establishing the effective date of a
regulation promulgated under this subsection, take
into account the differences in the manner in
which the different types of tobacco products have
historically been produced, the financial
resources of the different tobacco product
manufacturers, and the state of their existing
manufacturing facilities, and shall provide for a
reasonable period of time for such manufacturers
to conform to good manufacturing practices; and
``(v) not <<NOTE: Compliance date.>> require
any small tobacco product manufacturer to comply
with a regulation under subparagraph (A) for at
least 4 years following the effective date
established by the Secretary for such regulation.
``(2) Exemptions; variances.--
``(A) Petition.--Any person subject to any
requirement prescribed under paragraph (1) may petition
the Secretary for a permanent or temporary exemption or
variance from such requirement. Such a petition shall be
submitted to the Secretary in such form and manner as
the Secretary shall prescribe and shall--
``(i) in the case of a petition for an
exemption from a requirement, set forth the basis
for the petitioner's determination that compliance
with the requirement is not required to assure
that the tobacco product will be in compliance
with this chapter;
``(ii) in the case of a petition for a
variance from a requirement, set forth the methods
proposed to be used in, and the facilities and
controls proposed to be used for, the manufacture,
packing, and storage of the tobacco product in
lieu of the methods, facilities, and controls
prescribed by the requirement; and
``(iii) contain such other information as the
Secretary shall prescribe.
``(B) Referral to the tobacco products scientific
advisory committee.--The Secretary may refer to the
Tobacco Products Scientific Advisory Committee any
petition submitted under subparagraph
(A). <<NOTE: Reports. Deadline.>> The Tobacco Products
Scientific Advisory Committee shall report its
recommendations to the Secretary with respect to a
petition referred to it within 60 days after the date of
the petition's referral. Within 60 days after--
``(i) the date the petition was submitted to
the Secretary under subparagraph (A); or
``(ii) the day after the petition was referred
to the Tobacco Products Scientific Advisory
Committee,
whichever occurs later, the Secretary shall by order
either deny the petition or approve it.
``(C) Approval.--The Secretary may approve--
``(i) a petition for an exemption for a
tobacco product from a requirement if the
Secretary determines
[[Page 123 STAT. 1799]]
that compliance with such requirement is not
required to assure that the tobacco product will
be in compliance with this chapter; and
``(ii) a petition for a variance for a tobacco
product from a requirement if the Secretary
determines that the methods to be used in, and the
facilities and controls to be used for, the
manufacture, packing, and storage of the tobacco
product in lieu of the methods, facilities, and
controls prescribed by the requirement are
sufficient to assure that the tobacco product will
be in compliance with this chapter.
``(D) Conditions.--An order of the Secretary
approving a petition for a variance shall prescribe such
conditions respecting the methods used in, and the
facilities and controls used for, the manufacture,
packing, and storage of the tobacco product to be
granted the variance under the petition as may be
necessary to assure that the tobacco product will be in
compliance with this chapter.
``(E) Hearing.--After the issuance of an order under
subparagraph (B) respecting a petition, the petitioner
shall have an opportunity for an informal hearing on
such order.
``(3) Compliance.--Compliance with requirements under this
subsection shall not be required before the end of the 3-year
period following the date of enactment of the Family Smoking
Prevention and Tobacco Control Act.
``(f) Research and Development.--The Secretary may enter into
contracts for research, testing, and demonstrations respecting tobacco
products and may obtain tobacco products for research, testing, and
demonstration purposes.
``SEC. 907. <<NOTE: 21 USC 387g.>> TOBACCO PRODUCT STANDARDS.
``(a) In General.--
``(1) <<NOTE: Effective dates.>> Special rules.--
``(A) Special rule for cigarettes.--Beginning 3
months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, a cigarette or any
of its component parts (including the tobacco, filter,
or paper) shall not contain, as a constituent (including
a smoke constituent) or additive, an artificial or
natural flavor (other than tobacco or menthol) or an
herb or spice, including strawberry, grape, orange,
clove, cinnamon, pineapple, vanilla, coconut, licorice,
cocoa, chocolate, cherry, or coffee, that is a
characterizing flavor of the tobacco product or tobacco
smoke. Nothing in this subparagraph shall be construed
to limit the Secretary's authority to take action under
this section or other sections of this Act applicable to
menthol or any artificial or natural flavor, herb, or
spice not specified in this subparagraph.
``(B) Additional special rule.--Beginning 2 years
after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, a tobacco product
manufacturer shall not use tobacco, including foreign
grown tobacco, that contains a pesticide chemical
residue that is at a level greater than is specified by
any tolerance applicable under Federal law to
domestically grown tobacco.
[[Page 123 STAT. 1800]]
``(2) Revision of tobacco product standards.--The Secretary
may revise the tobacco product standards in paragraph (1) in
accordance with subsection (c).
``(3) Tobacco product standards.--
``(A) In general.--The Secretary may adopt tobacco
product standards in addition to those in paragraph (1)
if the Secretary finds that a tobacco product standard
is appropriate for the protection of the public health.
``(B) Determinations.--
``(i) Considerations.--In making a finding
described in subparagraph (A), the Secretary shall
consider scientific evidence concerning--
``(I) the risks and benefits to the
population as a whole, including users
and nonusers of tobacco products, of the
proposed standard;
``(II) the increased or decreased
likelihood that existing users of
tobacco products will stop using such
products; and
``(III) the increased or decreased
likelihood that those who do not use
tobacco products will start using such
products.
``(ii) Additional considerations.--In the
event that the Secretary makes a determination,
set forth in a proposed tobacco product standard
in a proposed rule, that it is appropriate for the
protection of public health to require the
reduction or elimination of an additive,
constituent (including a smoke constituent), or
other component of a tobacco product because the
Secretary has found that the additive,
constituent, or other component is or may be
harmful, any party objecting to the proposed
standard on the ground that the proposed standard
will not reduce or eliminate the risk of illness
or injury may provide for the Secretary's
consideration scientific evidence that
demonstrates that the proposed standard will not
reduce or eliminate the risk of illness or injury.
``(4) Content of tobacco product standards.--A tobacco
product standard established under this section for a tobacco
product--
``(A) shall include provisions that are appropriate
for the protection of the public health, including
provisions, where appropriate--
``(i) for nicotine yields of the product;
``(ii) for the reduction or elimination of
other constituents, including smoke constituents,
or harmful components of the product; or
``(iii) relating to any other requirement
under subparagraph (B);
``(B) shall, where appropriate for the protection of
the public health, include--
``(i) provisions respecting the construction,
components, ingredients, additives, constituents,
including smoke constituents, and properties of
the tobacco product;
``(ii) provisions for the testing (on a sample
basis or, if necessary, on an individual basis) of
the tobacco product;
[[Page 123 STAT. 1801]]
``(iii) provisions for the measurement of the
tobacco product characteristics of the tobacco
product;
``(iv) provisions requiring that the results
of each or of certain of the tests of the tobacco
product required to be made under clause (ii) show
that the tobacco product is in conformity with the
portions of the standard for which the test or
tests were required; and
``(v) a provision requiring that the sale and
distribution of the tobacco product be restricted
but only to the extent that the sale and
distribution of a tobacco product may be
restricted under a regulation under section
906(d);
``(C) shall, where appropriate, require the use and
prescribe the form and content of labeling for the
proper use of the tobacco product; and
``(D) shall require tobacco products containing
foreign-grown tobacco to meet the same standards
applicable to tobacco products containing domestically
grown tobacco.
``(5) Periodic reevaluation of tobacco product standards.--
The Secretary shall provide for periodic evaluation of tobacco
product standards established under this section to determine
whether such standards should be changed to reflect new medical,
scientific, or other technological data. The Secretary may
provide for testing under paragraph (4)(B) by any person.
``(6) Involvement of other agencies; informed persons.--In
carrying out duties under this section, the Secretary shall
endeavor to--
``(A) use personnel, facilities, and other technical
support available in other Federal agencies;
``(B) consult <<NOTE: Consultation.>> with other
Federal agencies concerned with standard setting and
other nationally or internationally recognized standard-
setting entities; and
``(C) invite appropriate participation, through
joint or other conferences, workshops, or other means,
by informed persons representative of scientific,
professional, industry, agricultural, or consumer
organizations who in the Secretary's judgment can make a
significant contribution.
``(b) Considerations by Secretary.--
``(1) Technical achievability.--The Secretary shall consider
information submitted in connection with a proposed standard
regarding the technical achievability of compliance with such
standard.
``(2) Other considerations.--The Secretary shall consider
all other information submitted in connection with a proposed
standard, including information concerning the countervailing
effects of the tobacco product standard on the health of
adolescent tobacco users, adult tobacco users, or nontobacco
users, such as the creation of a significant demand for
contraband or other tobacco products that do not meet the
requirements of this chapter and the significance of such
demand.
``(c) Proposed Standards.--
``(1) In general.--The Secretary <<NOTE: Federal Register,
publication. Notice.>> shall publish in the Federal Register a
notice of proposed rulemaking for the establishment, amendment,
or revocation of any tobacco product standard.
[[Page 123 STAT. 1802]]
``(2) Requirements of notice.--A notice of proposed
rulemaking for the establishment or amendment of a tobacco
product standard for a tobacco product shall--
``(A) set forth a finding with supporting
justification that the tobacco product standard is
appropriate for the protection of the public health;
``(B) invite interested persons to submit a draft or
proposed tobacco product standard for consideration by
the Secretary;
``(C) invite interested persons to submit comments
on structuring the standard so that it does not
advantage foreign-grown tobacco over domestically grown
tobacco; and
``(D) invite the Secretary of Agriculture to provide
any information or analysis which the Secretary of
Agriculture believes is relevant to the proposed tobacco
product standard.
``(3) Finding.--A notice of proposed rulemaking for the
revocation of a tobacco product standard shall set forth a
finding with supporting justification that the tobacco product
standard is no longer appropriate for the protection of the
public health.
``(4) Comment.--The Secretary shall provide for a comment
period of not less than 60 days.
``(d) Promulgation.--
``(1) In general.--After the expiration of the period for
comment on a notice of proposed rulemaking published under
subsection (c) respecting a tobacco product standard and after
consideration of comments submitted under subsections (b) and
(c) and any report from the Tobacco Products Scientific Advisory
Committee, the Secretary shall--
``(A) if <<NOTE: Regulations. Federal Register,
publication.>> the Secretary determines that the
standard would be appropriate for the protection of the
public health, promulgate a regulation establishing a
tobacco product standard and publish in the Federal
Register findings on the matters referred to in
subsection (c); or
``(B) publish <<NOTE: Publication. Notice.>> a
notice terminating the proceeding for the development of
the standard together with the reasons for such
termination.
``(2) Effective date.--A regulation establishing a tobacco
product standard shall set forth the date or dates upon which
the standard shall take effect, but no such regulation may take
effect before 1 year after the date of its publication unless
the Secretary determines that an earlier effective date is
necessary for the protection of the public health. Such date or
dates shall be established so as to minimize, consistent with
the public health, economic loss to, and disruption or
dislocation of, domestic and international trade. In
establishing such effective date or dates, the Secretary shall
consider information submitted in connection with a proposed
product standard by interested parties, including manufacturers
and tobacco growers, regarding the technical achievability of
compliance with the standard, and including information
concerning the existence of patents that make it impossible to
comply in the timeframe envisioned in the proposed standard. If
the Secretary determines, based on the Secretary's evaluation of
submitted comments, that a product standard can be met only by
manufacturers requiring substantial changes to the methods of
farming the domestically grown tobacco used by the manufacturer,
the
[[Page 123 STAT. 1803]]
effective date of that product standard shall be not less than 2
years after the date of publication of the final regulation
establishing the standard.
``(3) Limitation on power granted to the food and drug
administration.--Because of the importance of a decision of the
Secretary to issue a regulation--
``(A) banning all cigarettes, all smokeless tobacco
products, all little cigars, all cigars other than
little cigars, all pipe tobacco, or all roll-your-own
tobacco products; or
``(B) requiring the reduction of nicotine yields of
a tobacco product to zero,
the Secretary is prohibited from taking such actions under this
Act.
``(4) Amendment; revocation.--
``(A) Authority.--The Secretary, upon the
Secretary's own initiative or upon petition of an
interested person, may by a regulation, promulgated in
accordance with the requirements of subsection (c) and
paragraph (2), amend or revoke a tobacco product
standard.
``(B) Effective date.--The Secretary may declare a
proposed amendment of a tobacco product standard to be
effective on and after its publication in the Federal
Register and until the effective date of any final
action taken on such amendment if the Secretary
determines that making it so effective is in the public
interest.
``(5) Referral to advisory committee.--
``(A) In general.--The Secretary may refer a
proposed regulation for the establishment, amendment, or
revocation of a tobacco product standard to the Tobacco
Products Scientific Advisory Committee for a report and
recommendation with respect to any matter involved in
the proposed regulation which requires the exercise of
scientific judgment.
``(B) Initiation of referral.--The Secretary may
make a referral under this paragraph--
``(i) on the Secretary's own initiative; or
``(ii) upon the request of an interested
person that--
``(I) demonstrates good cause for
the referral; and
``(II) is <<NOTE: Deadline.>> made
before the expiration of the period for
submission of comments on the proposed
regulation.
``(C) Provision of data.--If a proposed regulation
is referred under this paragraph to the Tobacco Products
Scientific Advisory Committee, the Secretary shall
provide the Advisory Committee with the data and
information on which such proposed regulation is based.
``(D) <<NOTE: Statement.>> Report and
recommendation.--The Tobacco Products Scientific
Advisory Committee shall, within 60 days after the
referral of a proposed regulation under this paragraph
and after independent study of the data and information
furnished to it by the Secretary and other data and
information before it, submit to the Secretary a report
and recommendation respecting such regulation, together
with all underlying data and information and a statement
of the reason or basis for the recommendation.
[[Page 123 STAT. 1804]]
``(E) Public availability.--The Secretary shall make
a copy of each report and recommendation under
subparagraph (D) publicly available.
``(e) Menthol Cigarettes.--
``(1) Referral; considerations.--Immediately upon the
establishment of the Tobacco Products Scientific Advisory
Committee under section 917(a), the Secretary shall refer to the
Committee for report and recommendation, under section
917(c)(4), the issue of the impact of the use of menthol in
cigarettes on the public health, including such use among
children, African-Americans, Hispanics, and other racial and
ethnic minorities. In its review, the Tobacco Products
Scientific Advisory Committee shall address the considerations
listed in subsections (a)(3)(B)(i) and (b).
``(2) Report and recommendation.--Not later than 1 year
after its establishment, the Tobacco Product Scientific Advisory
Committee shall submit to the Secretary the report and
recommendations required pursuant to paragraph (1).
``(3) Rule of construction.--Nothing in this subsection
shall be construed to limit the Secretary's authority to take
action under this section or other sections of this Act
applicable to menthol.
``(f) Dissolvable Tobacco Products.--
``(1) Referral; considerations.--The Secretary shall refer
to the Tobacco Products Scientific Advisory Committee for report
and recommendation, under section 917(c)(4), the issue of the
nature and impact of the use of dissolvable tobacco products on
the public health, including such use among children. In its
review, the Tobacco Products Scientific Advisory Committee shall
address the considerations listed in subsection (a)(3)(B)(i).
``(2) Report and recommendation.--Not later than 2 years
after its establishment, the Tobacco Product Scientific Advisory
Committee shall submit to the Secretary the report and
recommendations required pursuant to paragraph (1).
``(3) Rule of construction.--Nothing in this subsection
shall be construed to limit the Secretary's authority to take
action under this section or other sections of this Act at any
time applicable to any dissolvable tobacco product.
``SEC. 908. <<NOTE: 21 USC 387h.>> NOTIFICATION AND OTHER
REMEDIES.
``(a) Notification.--If the Secretary determines that--
``(1) a tobacco product which is introduced or delivered for
introduction into interstate commerce for commercial
distribution presents an unreasonable risk of substantial harm
to the public health; and
``(2) notification under this subsection is necessary to
eliminate the unreasonable risk of such harm and no more
practicable means is available under the provisions of this
chapter (other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to assure that
adequate notification is provided in an appropriate form, by the persons
and means best suited under the circumstances involved, to all persons
who should properly receive such notification in order to eliminate such
risk. The Secretary may order notification by any appropriate means,
including public service announcements.
[[Page 123 STAT. 1805]]
Before issuing <<NOTE: Consultation.>> an order under this subsection,
the Secretary shall consult with the persons who are to give notice
under the order.
``(b) No Exemption From Other Liability.--Compliance with an order
issued under this section shall not relieve any person from liability
under Federal or State law. In awarding damages for economic loss in an
action brought for the enforcement of any such liability, the value to
the plaintiff in such action of any remedy provided under such order
shall be taken into account.
``(c) Recall Authority.--
``(1) In general.--If the <<NOTE: Order.>> Secretary finds
that there is a reasonable probability that a tobacco product
contains a manufacturing or other defect not ordinarily
contained in tobacco products on the market that would cause
serious, adverse health consequences or death, the Secretary
shall issue an order requiring the appropriate person (including
the manufacturers, importers, distributors, or retailers of the
tobacco product) to immediately cease distribution of such
tobacco product. The <<NOTE: Deadline.>> order shall provide
the person subject to the order with an opportunity for an
informal hearing, to be held not later than 10 days after the
date of the issuance of the order, on the actions required by
the order and on whether the order should be amended to require
a recall of such tobacco product. If, after providing an
opportunity for such a hearing, the Secretary determines that
inadequate grounds exist to support the actions required by the
order, the Secretary shall vacate the order.
``(2) Amendment of order to require recall.--
``(A) In general.--If, after providing an
opportunity for an informal hearing under paragraph (1),
the Secretary determines that the order should be
amended to include a recall of the tobacco product with
respect to which the order was issued, the Secretary
shall, except as provided in subparagraph (B), amend the
order to require a recall. The
Secretary <<NOTE: Timetable. Reports.>> shall specify a
timetable in which the tobacco product recall will occur
and shall require periodic reports to the Secretary
describing the progress of the recall.
``(B) Notice.--An amended order under subparagraph
(A)--
``(i) shall not include recall of a tobacco
product from individuals; and
``(ii) shall provide for notice to persons
subject to the risks associated with the use of
such tobacco product.
In providing the notice required by clause (ii), the
Secretary may use the assistance of retailers and other
persons who distributed such tobacco
product. <<NOTE: Notification.>> If a significant
number of such persons cannot be identified, the
Secretary shall notify such persons under section
705(b).
``(3) Remedy not exclusive.--The remedy provided by this
subsection shall be in addition to remedies provided by
subsection (a).
``SEC. 909. <<NOTE: Regulations. 21 USC 387i.>> RECORDS AND
REPORTS ON TOBACCO PRODUCTS.
``(a) In General.--Every person who is a tobacco product
manufacturer or importer of a tobacco product shall establish and
maintain such records, make such reports, and provide such information,
as the Secretary may by regulation reasonably require to assure
[[Page 123 STAT. 1806]]
that such tobacco product is not adulterated or misbranded and to
otherwise protect public health. Regulations prescribed under the
preceding sentence--
``(1) may require a tobacco product manufacturer or importer
to report to the Secretary whenever the manufacturer or importer
receives or otherwise becomes aware of information that
reasonably suggests that one of its marketed tobacco products
may have caused or contributed to a serious unexpected adverse
experience associated with the use of the product or any
significant increase in the frequency of a serious, expected
adverse product experience;
``(2) shall require reporting of other significant adverse
tobacco product experiences as determined by the Secretary to be
necessary to be reported;
``(3) shall not impose requirements unduly burdensome to a
tobacco product manufacturer or importer, taking into account
the cost of complying with such requirements and the need for
the protection of the public health and the implementation of
this chapter;
``(4) when prescribing the procedure for making requests for
reports or information, shall require that each request made
under such regulations for submission of a report or information
to the Secretary state the reason or purpose for such request
and identify to the fullest extent practicable such report or
information;
``(5) when requiring submission of a report or information
to the Secretary, shall state the reason or purpose for the
submission of such report or information and identify to the
fullest extent practicable such report or information; and
``(6) may not require that the identity of any patient or
user be disclosed in records, reports, or information required
under this subsection unless required for the medical welfare of
an individual, to determine risks to public health of a tobacco
product, or to verify a record, report, or information submitted
under this chapter.
In prescribing regulations under this subsection, the Secretary shall
have due regard for the professional ethics of the medical profession
and the interests of patients. <<NOTE: Applicability.>> The
prohibitions of paragraph (6) continue to apply to records, reports, and
information concerning any individual who has been a patient,
irrespective of whether or when he ceases to be a patient.
``(b) Reports of Removals and Corrections.--
``(1) In general.--Except as provided in paragraph (2), the
Secretary shall by regulation require a tobacco product
manufacturer or importer of a tobacco product to report promptly
to the Secretary any corrective action taken or removal from the
market of a tobacco product undertaken by such manufacturer or
importer if the removal or correction was undertaken--
``(A) to reduce a risk to health posed by the
tobacco product; or
``(B) to remedy a violation of this chapter caused
by the tobacco product which may present a risk to
health.
A tobacco product manufacturer or importer of a tobacco product
who undertakes a corrective action or removal from the market of
a tobacco product which is not required to be
[[Page 123 STAT. 1807]]
reported under this subsection shall keep a record of such
correction or removal.
``(2) Exception.--No report of the corrective action or
removal of a tobacco product may be required under paragraph (1)
if a report of the corrective action or removal is required and
has been submitted under subsection (a).
``SEC. 910. <<NOTE: 21 USC 387j.>> APPLICATION FOR REVIEW OF
CERTAIN TOBACCO PRODUCTS.
``(a) In General.--
``(1) New tobacco product defined.--For purposes of this
section the term `new tobacco product' means--
``(A) any tobacco product (including those products
in test markets) that was not commercially marketed in
the United States as of February 15, 2007; or
``(B) any modification (including a change in
design, any component, any part, or any constituent,
including a smoke constituent, or in the content,
delivery or form of nicotine, or any other additive or
ingredient) of a tobacco product where the modified
product was commercially marketed in the United States
after February 15, 2007.
``(2) Premarket review required.--
``(A) New products.--An order under subsection
(c)(1)(A)(i) for a new tobacco product is required
unless--
``(i) the manufacturer has submitted a report
under section 905(j); and the Secretary has issued
an order that the tobacco product--
``(I) is substantially equivalent to
a tobacco product commercially marketed
(other than for test marketing) in the
United States as of February 15, 2007;
and
``(II) is in compliance with the
requirements of this Act; or
``(ii) the tobacco product is exempt from the
requirements of section 905(j) pursuant to a
regulation issued under section 905(j)(3).
``(B) Application to certain post-february 15, 2007,
products.--Subparagraph (A) shall not apply to a tobacco
product--
``(i) that was first introduced or delivered
for introduction into interstate commerce for
commercial distribution in the United States after
February 15, 2007, and prior to the date that is
21 months after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act;
and
``(ii) for which a report was submitted under
section 905(j) within such 21-month period,
except that subparagraph (A) shall apply to the tobacco
product if the Secretary issues an order that the
tobacco product is not substantially equivalent.
``(3) Substantially equivalent defined.--
``(A) In general.--In this section and section
905(j), the term `substantially equivalent' or
`substantial equivalence' means, with respect to the
tobacco product being compared to the predicate tobacco
product, that the Secretary by order has found that the
tobacco product--
[[Page 123 STAT. 1808]]
``(i) has the same characteristics as the
predicate tobacco product; or
``(ii) has different characteristics and the
information submitted contains information,
including clinical data if deemed necessary by the
Secretary, that demonstrates that it is not
appropriate to regulate the product under this
section because the product does not raise
different questions of public health.
``(B) Characteristics.--In subparagraph (A), the
term `characteristics' means the materials, ingredients,
design, composition, heating source, or other features
of a tobacco product.
``(C) Limitation.--A tobacco product may not be
found to be substantially equivalent to a predicate
tobacco product that has been removed from the market at
the initiative of the Secretary or that has been
determined by a judicial order to be misbranded or
adulterated.
``(4) Health information.--
``(A) Summary.--As part of a submission under
section 905(j) respecting a tobacco product, the person
required to file a premarket notification under such
section shall provide an adequate summary of any health
information related to the tobacco product or state that
such information will be made available upon request by
any person.
``(B) Required information.--Any
summary <<NOTE: Public information. Deadline.>> under
subparagraph (A) respecting a tobacco product shall
contain detailed information regarding data concerning
adverse health effects and shall be made available to
the public by the Secretary within 30 days of the
issuance of a determination that such tobacco product is
substantially equivalent to another tobacco product.
``(b) Application.--
``(1) Contents.--An application under this section shall
contain--
``(A) full reports of all information, published or
known to, or which should reasonably be known to, the
applicant, concerning investigations which have been
made to show the health risks of such tobacco product
and whether such tobacco product presents less risk than
other tobacco products;
``(B) a full statement of the components,
ingredients, additives, and properties, and of the
principle or principles of operation, of such tobacco
product;
``(C) a full description of the methods used in, and
the facilities and controls used for, the manufacture,
processing, and, when relevant, packing and installation
of, such tobacco product;
``(D) an identifying reference to any tobacco
product standard under section 907 which would be
applicable to any aspect of such tobacco product, and
either adequate information to show that such aspect of
such tobacco product fully meets such tobacco product
standard or adequate information to justify any
deviation from such standard;
``(E) such samples of such tobacco product and of
components thereof as the Secretary may reasonably
require;
[[Page 123 STAT. 1809]]
``(F) specimens of the labeling proposed to be used
for such tobacco product; and
``(G) such other information relevant to the subject
matter of the application as the Secretary may require.
``(2) Referral to tobacco products scientific advisory
committee.--Upon receipt of an application meeting the
requirements set forth in paragraph (1), the Secretary--
``(A) may, on the Secretary's own initiative; or
``(B) may, upon the request of an applicant,
refer such application to the Tobacco Products Scientific
Advisory Committee for reference and for submission (within such
period as the Secretary may establish) of a report and
recommendation respecting the application, together with all
underlying data and the reasons or basis for the recommendation.
``(c) Action on Application.--
``(1) Deadline.--
``(A) In general.--As promptly as possible, but in
no event later than 180 days after the receipt of an
application under subsection (b), the Secretary, after
considering the report and recommendation submitted
under subsection (b)(2), shall--
``(i) issue an order that the new product may
be introduced or delivered for introduction into
interstate commerce if the Secretary finds that
none of the grounds specified in paragraph (2) of
this subsection applies; or
``(ii) issue an order that the new product may
not be introduced or delivered for introduction
into interstate commerce if the Secretary finds
(and sets forth the basis for such finding as part
of or accompanying such denial) that 1 or more
grounds for denial specified in paragraph (2) of
this subsection apply.
``(B) Restrictions on sale and distribution.--An
order under subparagraph (A)(i) may require that the
sale and distribution of the tobacco product be
restricted but only to the extent that the sale and
distribution of a tobacco product may be restricted
under a regulation under section 906(d).
``(2) Denial of application.--The Secretary shall deny an
application submitted under subsection (b) if, upon the basis of
the information submitted to the Secretary as part of the
application and any other information before the Secretary with
respect to such tobacco product, the Secretary finds that--
``(A) there is a lack of a showing that permitting
such tobacco product to be marketed would be appropriate
for the protection of the public health;
``(B) the methods used in, or the facilities or
controls used for, the manufacture, processing, or
packing of such tobacco product do not conform to the
requirements of section 906(e);
``(C) based on a fair evaluation of all material
facts, the proposed labeling is false or misleading in
any particular; or
``(D) such tobacco product is not shown to conform
in all respects to a tobacco product standard in effect
under
[[Page 123 STAT. 1810]]
section 907, and there is a lack of adequate information
to justify the deviation from such standard.
``(3) Denial information.--Any denial <<NOTE: Statement.>>
of an application shall, insofar as the Secretary determines to
be practicable, be accompanied by a statement informing the
applicant of the measures required to remove such application
from deniable form (which measures may include further research
by the applicant in accordance with 1 or more protocols
prescribed by the Secretary).
``(4) Basis for finding.--For purposes of this section, the
finding as to whether the marketing of a tobacco product for
which an application has been submitted is appropriate for the
protection of the public health shall be determined with respect
to the risks and benefits to the population as a whole,
including users and nonusers of the tobacco product, and taking
into account--
``(A) the increased or decreased likelihood that
existing users of tobacco products will stop using such
products; and
``(B) the increased or decreased likelihood that
those who do not use tobacco products will start using
such products.
``(5) Basis for action.--
``(A) Investigations.--For purposes of paragraph
(2)(A), whether permitting a tobacco product to be
marketed would be appropriate for the protection of the
public health shall, when appropriate, be determined on
the basis of well-controlled investigations, which may
include 1 or more clinical investigations by experts
qualified by training and experience to evaluate the
tobacco product.
``(B) Other evidence.--If the Secretary determines
that there exists valid scientific evidence (other than
evidence derived from investigations described in
subparagraph (A)) which is sufficient to evaluate the
tobacco product, the Secretary may authorize that the
determination for purposes of paragraph (2)(A) be made
on the basis of such evidence.
``(d) Withdrawal and Temporary Suspension.--
``(1) In general.--The
Secretary <<NOTE: Notice. Hearings.>> shall, upon obtaining,
where appropriate, advice on scientific matters from the Tobacco
Products Scientific Advisory Committee, and after due notice and
opportunity for informal hearing for a tobacco product for which
an order was issued under subsection (c)(1)(A)(i), issue an
order withdrawing the order if the Secretary finds--
``(A) that the continued marketing of such tobacco
product no longer is appropriate for the protection of
the public health;
``(B) that the application contained or was
accompanied by an untrue statement of a material fact;
``(C) that the applicant--
``(i) has failed to establish a system for
maintaining records, or has repeatedly or
deliberately failed to maintain records or to make
reports, required by an applicable regulation
under section 909;
[[Page 123 STAT. 1811]]
``(ii) has refused to permit access to, or
copying or verification of, such records as
required by section 704; or
``(iii) has not complied with the requirements
of section 905;
``(D) on the basis of new information before the
Secretary with respect to such tobacco product,
evaluated together with the evidence before the
Secretary when the application was reviewed, that the
methods used in, or the facilities and controls used
for, the manufacture, processing, packing, or
installation of such tobacco product do not conform with
the requirements of section 906(e) and were not brought
into conformity with such requirements within a
reasonable time after receipt of written notice from the
Secretary of nonconformity;
``(E) on the basis of new information before the
Secretary, evaluated together with the evidence before
the Secretary when the application was reviewed, that
the labeling of such tobacco product, based on a fair
evaluation of all material facts, is false or misleading
in any particular and was not corrected within a
reasonable time after receipt of written notice from the
Secretary of such fact; or
``(F) on the basis of new information before the
Secretary, evaluated together with the evidence before
the Secretary when such order was issued, that such
tobacco product is not shown to conform in all respects
to a tobacco product standard which is in effect under
section 907, compliance with which was a condition to
the issuance of an order relating to the application,
and that there is a lack of adequate information to
justify the deviation from such standard.
``(2) Appeal.--The holder of an application subject to an
order issued under paragraph (1) withdrawing an order issued
pursuant to subsection (c)(1)(A)(i) may, by petition filed on or
before the 30th day after the date upon which such holder
receives notice of such withdrawal, obtain review thereof in
accordance with section 912.
``(3) <<NOTE: Order.>> Temporary suspension.--If, after
providing an opportunity for an informal hearing, the Secretary
determines there is reasonable probability that the continuation
of distribution of a tobacco product under an order would cause
serious, adverse health consequences or death, that is greater
than ordinarily caused by tobacco products on the market, the
Secretary shall by order temporarily suspend the authority of
the manufacturer to market the product. If the Secretary issues
such an order, the Secretary shall proceed expeditiously under
paragraph (1) to withdraw such application.
``(e) Service of Order.--An order issued by the Secretary under this
section shall be served--
``(1) in person by any officer or employee of the department
designated by the Secretary; or
``(2) by mailing the order by registered mail or certified
mail addressed to the applicant at the applicant's last known
address in the records of the Secretary.
``(f) Records.--
``(1) Additional information.--In the <<NOTE: Reports.>>
case of any tobacco product for which an order issued pursuant
to subsection
[[Page 123 STAT. 1812]]
(c)(1)(A)(i) for an application filed under subsection (b) is in
effect, the applicant shall establish and maintain such records,
and make such reports to the Secretary, as the Secretary may by
regulation, or by order with respect to such application,
prescribe on the basis of a finding that such records and
reports are necessary in order to enable the Secretary to
determine, or facilitate a determination of, whether there is or
may be grounds for withdrawing or temporarily suspending such
order.
``(2) Access to records.--Each person required under this
section to maintain records, and each person in charge of
custody thereof, shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee at
all reasonable times to have access to and copy and verify such
records.
``(g) Investigational Tobacco Product Exemption for Investigational
Use.--The Secretary may exempt tobacco products intended for
investigational use from the provisions of this chapter under such
conditions as the Secretary may by regulation prescribe.
``SEC. 911. <<NOTE: 21 USC 387k.>> MODIFIED RISK TOBACCO
PRODUCTS.
``(a) In General.--No person may introduce or deliver for
introduction into interstate commerce any modified risk tobacco product
unless an order issued pursuant to subsection (g) is effective with
respect to such product.
``(b) Definitions.--In this section:
``(1) Modified risk tobacco product.--The term `modified
risk tobacco product' means any tobacco product that is sold or
distributed for use to reduce harm or the risk of tobacco-
related disease associated with commercially marketed tobacco
products.
``(2) Sold or distributed.--
``(A) In general.--With respect to a tobacco
product, the term `sold or distributed for use to reduce
harm or the risk of tobacco-related disease associated
with commercially marketed tobacco products' means a
tobacco product--
``(i) the label, labeling, or advertising of
which represents explicitly or implicitly that--
``(I) the tobacco product presents a
lower risk of tobacco-related disease or
is less harmful than one or more other
commercially marketed tobacco products;
``(II) the tobacco product or its
smoke contains a reduced level of a
substance or presents a reduced exposure
to a substance; or
``(III) the tobacco product or its
smoke does not contain or is free of a
substance;
``(ii) the label, labeling, or advertising of
which uses the descriptors `light', `mild', or
`low' or similar descriptors; or
``(iii) the tobacco product manufacturer of
which has taken any action directed to consumers
through the media or otherwise, other than by
means of the tobacco product's label, labeling, or
advertising, after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act,
respecting the product
[[Page 123 STAT. 1813]]
that would be reasonably expected to result in
consumers believing that the tobacco product or
its smoke may present a lower risk of disease or
is less harmful than one or more commercially
marketed tobacco products, or presents a reduced
exposure to, or does not contain or is free of, a
substance or substances.
``(B) Limitation.--No tobacco product shall be
considered to be `sold or distributed for use to reduce
harm or the risk of tobacco-related disease associated
with commercially marketed tobacco products', except as
described in subparagraph (A).
``(C) Smokeless tobacco product.--No smokeless
tobacco product shall be considered to be `sold or
distributed for use to reduce harm or the risk of
tobacco-related disease associated with commercially
marketed tobacco products' solely because its label,
labeling, or advertising uses the following phrases to
describe such product and its use: `smokeless tobacco',
`smokeless tobacco product', `not consumed by smoking',
`does not produce smoke', `smokefree', `smoke-free',
`without smoke', `no smoke', or `not smoke'.
``(3) Effective date.--The provisions of paragraph
(2)(A)(ii) shall take effect 12 months after the date of
enactment of the Family Smoking Prevention and Tobacco Control
Act for those products whose label, labeling, or advertising
contains the terms described in such paragraph on such date of
enactment. The effective date shall be with respect to the date
of manufacture, provided that, in any case, beginning 30 days
after such effective date, a manufacturer shall not introduce
into the domestic commerce of the United States any product,
irrespective of the date of manufacture, that is not in
conformance with paragraph (2)(A)(ii).
``(c) Tobacco Dependence Products.--A product that is intended to be
used for the treatment of tobacco dependence, including smoking
cessation, is not a modified risk tobacco product under this section if
it has been approved as a drug or device by the Food and Drug
Administration and is subject to the requirements of chapter V.
``(d) Filing.--Any person may file with the Secretary an application
for a modified risk tobacco product. Such application shall include--
``(1) a description of the proposed product and any proposed
advertising and labeling;
``(2) the conditions for using the product;
``(3) the formulation of the product;
``(4) sample product labels and labeling;
``(5) all documents (including underlying scientific
information) relating to research findings conducted, supported,
or possessed by the tobacco product manufacturer relating to the
effect of the product on tobacco-related diseases and health-
related conditions, including information both favorable and
unfavorable to the ability of the product to reduce risk or
exposure and relating to human health;
``(6) data and information on how consumers actually use the
tobacco product; and
``(7) such other information as the Secretary may require.
``(e) Public Availability.--The Secretary <<NOTE: Comment period.>>
shall make the application described in subsection (d) publicly
available (except
[[Page 123 STAT. 1814]]
matters in the application which are trade secrets or otherwise
confidential, commercial information) and shall request comments by
interested persons on the information contained in the application and
on the label, labeling, and advertising accompanying such application.
``(f) Advisory Committee.--
``(1) In general.--The Secretary shall refer to the Tobacco
Products Scientific Advisory Committee any application submitted
under this section.
``(2) Recommendations.--Not
later <<NOTE: Deadline. Reports.>> than 60 days after the date
an application is referred to the Tobacco Products Scientific
Advisory Committee under paragraph (1), the Advisory Committee
shall report its recommendations on the application to the
Secretary.
``(g) Marketing.--
``(1) <<NOTE: Order.>> Modified risk products.--Except as
provided in paragraph (2), the Secretary shall, with respect to
an application submitted under this section, issue an order that
a modified risk product may be commercially marketed only if the
Secretary determines that the applicant has demonstrated that
such product, as it is actually used by consumers, will--
``(A) significantly reduce harm and the risk of
tobacco-related disease to individual tobacco users; and
``(B) benefit the health of the population as a
whole taking into account both users of tobacco products
and persons who do not currently use tobacco products.
``(2) Special rule for certain products.--
``(A) In general.--The Secretary may issue an order
that a tobacco product may be introduced or delivered
for introduction into interstate commerce, pursuant to
an application under this section, with respect to a
tobacco product that may not be commercially marketed
under paragraph (1) if the Secretary makes the findings
required under this paragraph and determines that the
applicant has demonstrated that--
``(i) such order would be appropriate to
promote the public health;
``(ii) any aspect of the label, labeling, and
advertising for such product that would cause the
tobacco product to be a modified risk tobacco
product under subsection (b) is limited to an
explicit or implicit representation that such
tobacco product or its smoke does not contain or
is free of a substance or contains a reduced level
of a substance, or presents a reduced exposure to
a substance in tobacco smoke;
``(iii) scientific evidence is not available
and, using the best available scientific methods,
cannot be made available without conducting long-
term epidemiological studies for an application to
meet the standards set forth in paragraph (1); and
``(iv) the scientific evidence that is
available without conducting long-term
epidemiological studies demonstrates that a
measurable and substantial reduction in morbidity
or mortality among individual tobacco users is
reasonably likely in subsequent studies.
[[Page 123 STAT. 1815]]
``(B) Additional findings required.--To issue an
order under subparagraph (A) the Secretary must also
find that the applicant has demonstrated that--
``(i) the magnitude of the overall reductions
in exposure to the substance or substances which
are the subject of the application is substantial,
such substance or substances are harmful, and the
product as actually used exposes consumers to the
specified reduced level of the substance or
substances;
``(ii) the product as actually used by
consumers will not expose them to higher levels of
other harmful substances compared to the similar
types of tobacco products then on the market
unless such increases are minimal and the
reasonably likely overall impact of use of the
product remains a substantial and measurable
reduction in overall morbidity and mortality among
individual tobacco users;
``(iii) testing of actual consumer perception
shows that, as the applicant proposes to label and
market the product, consumers will not be misled
into believing that the product--
``(I) is or has been demonstrated to
be less harmful; or
``(II) presents or has been
demonstrated to present less of a risk
of disease than 1 or more other
commercially marketed tobacco products;
and
``(iv) issuance of an order with respect to
the application is expected to benefit the health
of the population as a whole taking into account
both users of tobacco products and persons who do
not currently use tobacco products.
``(C) Conditions of marketing.--
``(i) In general.--Applications subject to an
order under this paragraph shall be limited to a
term of not more than 5 years, but may be renewed
upon a finding by the Secretary that the
requirements of this paragraph continue to be
satisfied based on the filing of a new
application.
``(ii) Agreements by applicant.--An
order <<NOTE: Study.>> under this paragraph shall
be conditioned on the applicant's agreement to
conduct postmarket surveillance and studies and to
submit to the Secretary the results of such
surveillance and studies to determine the impact
of the order on consumer perception, behavior, and
health and to enable the Secretary to review the
accuracy of the determinations upon which the
order was based in accordance with a protocol
approved by the Secretary.
``(iii) Annual submission.--The results of
such postmarket surveillance and studies described
in clause (ii) shall be submitted annually.
``(3) Basis.--The determinations under paragraphs (1) and
(2) shall be based on--
``(A) the scientific evidence submitted by the
applicant; and
[[Page 123 STAT. 1816]]
``(B) scientific evidence and other information that
is made available to the Secretary.
``(4) Benefit to health of individuals and of population as
a whole.--In making the determinations under paragraphs (1) and
(2), the Secretary shall take into account--
``(A) the relative health risks to individuals of
the tobacco product that is the subject of the
application;
``(B) the increased or decreased likelihood that
existing users of tobacco products who would otherwise
stop using such products will switch to the tobacco
product that is the subject of the application;
``(C) the increased or decreased likelihood that
persons who do not use tobacco products will start using
the tobacco product that is the subject of the
application;
``(D) the risks and benefits to persons from the use
of the tobacco product that is the subject of the
application as compared to the use of products for
smoking cessation approved under chapter V to treat
nicotine dependence; and
``(E) comments, data, and information submitted by
interested persons.
``(h) Additional Conditions for Marketing.--
``(1) Modified risk products.--The Secretary shall require
for the marketing of a product under this section that any
advertising or labeling concerning modified risk products enable
the public to comprehend the information concerning modified
risk and to understand the relative significance of such
information in the context of total health and in relation to
all of the diseases and health-related conditions associated
with the use of tobacco products.
``(2) Comparative claims.--
``(A) In general.--The Secretary may require for the
marketing of a product under this subsection that a
claim comparing a tobacco product to 1 or more other
commercially marketed tobacco products shall compare the
tobacco product to a commercially marketed tobacco
product that is representative of that type of tobacco
product on the market (for example the average value of
the top 3 brands of an established regular tobacco
product).
``(B) Quantitative comparisons.--The Secretary may
also require, for purposes of subparagraph (A), that the
percent (or fraction) of change and identity of the
reference tobacco product and a quantitative comparison
of the amount of the substance claimed to be reduced
shall be stated in immediate proximity to the most
prominent claim.
``(3) Label disclosure.--
``(A) In general.--The Secretary may require the
disclosure on the label of other substances in the
tobacco product, or substances that may be produced by
the consumption of that tobacco product, that may affect
a disease or health-related condition or may increase
the risk of other diseases or health-related conditions
associated with the use of tobacco products.
``(B) Conditions of use.--If the conditions of use
of the tobacco product may affect the risk of the
product to human health, the Secretary may require the
labeling of conditions of use.
[[Page 123 STAT. 1817]]
``(4) Time.--An order issued under subsection (g)(1) shall
be effective for a specified period of time.
``(5) Advertising.--The Secretary may require, with respect
to a product for which an applicant obtained an order under
subsection (g)(1), that the product comply with requirements
relating to advertising and promotion of the tobacco product.
``(i) Postmarket Surveillance and Studies.--
``(1) In general.--The Secretary shall require, with respect
to a product for which an applicant obtained an order under
subsection (g)(1), that the applicant conduct postmarket
surveillance and studies for such a tobacco product to determine
the impact of the order issuance on consumer perception,
behavior, and health, to enable the Secretary to review the
accuracy of the determinations upon which the order was based,
and to provide information that the Secretary determines is
otherwise necessary regarding the use or health risks involving
the tobacco product. <<NOTE: Deadline.>> The results of
postmarket surveillance and studies shall be submitted to the
Secretary on an annual basis.
``(2) <<NOTE: Deadlines. Notice.>> Surveillance protocol.--
Each applicant required to conduct a surveillance of a tobacco
product under paragraph (1) shall, within 30 days after
receiving notice that the applicant is required to conduct such
surveillance, submit, for the approval of the Secretary, a
protocol for the required surveillance. The Secretary, within 60
days of the receipt of such protocol, shall determine if the
principal investigator proposed to be used in the surveillance
has sufficient qualifications and experience to conduct such
surveillance and if such protocol will result in collection of
the data or other information designated by the Secretary as
necessary to protect the public health.
``(j) Withdrawal of Authorization.--The
Secretary, <<NOTE: Hearings.>> after an opportunity for an informal
hearing, shall withdraw an order under subsection (g) if the Secretary
determines that--
``(1) the applicant, based on new information, can no longer
make the demonstrations required under subsection (g), or the
Secretary can no longer make the determinations required under
subsection (g);
``(2) the application failed to include material information
or included any untrue statement of material fact;
``(3) any explicit or implicit representation that the
product reduces risk or exposure is no longer valid, including
if--
``(A) a tobacco product standard is established
pursuant to section 907;
``(B) an action is taken that affects the risks
presented by other commercially marketed tobacco
products that were compared to the product that is the
subject of the application; or
``(C) any postmarket surveillance or studies reveal
that the order is no longer consistent with the
protection of the public health;
``(4) the applicant failed to conduct or submit the
postmarket surveillance and studies required under subsection
(g)(2)(C)(ii) or subsection (i); or
``(5) the applicant failed to meet a condition imposed under
subsection (h).
[[Page 123 STAT. 1818]]
``(k) Chapter IV or V.--A product for which the Secretary has issued
an order pursuant to subsection (g) shall not be subject to chapter IV
or V.
``(l) Implementing Regulations or Guidance.--
``(1) Scientific evidence.--Not later <<NOTE: Deadline.>>
than 2 years after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, the Secretary shall issue
regulations or guidance (or any combination thereof) on the
scientific evidence required for assessment and ongoing review
of modified risk tobacco products. Such regulations or guidance
shall--
``(A) to the extent that adequate scientific
evidence exists, establish minimum standards for
scientific studies needed prior to issuing an order
under subsection (g) to show that a substantial
reduction in morbidity or mortality among individual
tobacco users occurs for products described in
subsection (g)(1) or is reasonably likely for products
described in subsection (g)(2);
``(B) include validated biomarkers, intermediate
clinical endpoints, and other feasible outcome measures,
as appropriate;
``(C) establish minimum standards for postmarket
studies, that shall include regular and long-term
assessments of health outcomes and mortality,
intermediate clinical endpoints, consumer perception of
harm reduction, and the impact on quitting behavior and
new use of tobacco products, as appropriate;
``(D) establish minimum standards for required
postmarket surveillance, including ongoing assessments
of consumer perception;
``(E) require that data from the required studies
and surveillance be made available to the Secretary
prior to the decision on renewal of a modified risk
tobacco product; and
``(F) establish a reasonable timetable for the
Secretary to review an application under this section.
``(2) Consultation.--The regulations or guidance issued
under paragraph (1) shall be developed in consultation with the
Institute of Medicine, and with the input of other appropriate
scientific and medical experts, on the design and conduct of
such studies and surveillance.
``(3) Revision.--The regulations or guidance under paragraph
(1) shall be revised on a regular basis as new scientific
information becomes available.
``(4) New tobacco products.--Not later <<NOTE: Deadline.>>
than 2 years after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, the Secretary shall issue a
regulation or guidance that permits the filing of a single
application for any tobacco product that is a new tobacco
product under section 910 and which the applicant seeks to
commercially market under this section.
``(m) Distributors.--Except as provided in this section, no
distributor may take any action, after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, with respect to a
tobacco product that would reasonably be expected to result in consumers
believing that the tobacco product or its smoke may present a lower risk
of disease or is less harmful
[[Page 123 STAT. 1819]]
than one or more commercially marketed tobacco products, or presents a
reduced exposure to, or does not contain or is free of, a substance or
substances.
``SEC. 912. <<NOTE: 21 USC 387l.>> JUDICIAL REVIEW.
``(a) Right To Review.--
``(1) In general.--Not later <<NOTE: Deadline.>> than 30
days after--
``(A) the promulgation of a regulation under section
907 establishing, amending, or revoking a tobacco
product standard; or
``(B) a denial of an application under section
910(c),
any person adversely affected by such regulation or denial may
file a petition for judicial review of such regulation or denial
with the United States Court of Appeals for the District of
Columbia or for the circuit in which such person resides or has
their principal place of business.
``(2) Requirements.--
``(A) Copy of petition.--A copy of the petition
filed under paragraph (1) shall be transmitted by the
clerk of the court involved to the Secretary.
``(B) Record of proceedings.--On receipt of a
petition under subparagraph (A), the Secretary shall
file in the court in which such petition was filed--
``(i) the record of the proceedings on which
the regulation or order was based; and
``(ii) a <<NOTE: Statement.>> statement of
the reasons for the issuance of such a regulation
or order.
``(C) Definition of record.--In this section, the
term `record' means--
``(i) all notices and other matter published
in the Federal Register with respect to the
regulation or order reviewed;
``(ii) all information submitted to the
Secretary with respect to such regulation or
order;
``(iii) proceedings of any panel or advisory
committee with respect to such regulation or
order;
``(iv) any hearing held with respect to such
regulation or order; and
``(v) any other information identified by the
Secretary, in the administrative proceeding held
with respect to such regulation or order, as being
relevant to such regulation or order.
``(b) Standard of Review.--Upon the filing of the petition under
subsection (a) for judicial review of a regulation or order, the court
shall have jurisdiction to review the regulation or order in accordance
with chapter 7 of title 5, United States Code, and to grant appropriate
relief, including interim relief, as provided for in such chapter. A
regulation or denial described in subsection (a) shall be reviewed in
accordance with section 706(2)(A) of title 5, United States Code.
``(c) Finality of Judgment.--The judgment of the court affirming or
setting aside, in whole or in part, any regulation or order shall be
final, subject to review by the Supreme Court of the United States upon
certiorari or certification, as provided in section 1254 of title 28,
United States Code.
[[Page 123 STAT. 1820]]
``(d) Other Remedies.--The remedies provided for in this section
shall be in addition to, and not in lieu of, any other remedies provided
by law.
``(e) Regulations and Orders Must Recite Basis in Record.--To
facilitate <<NOTE: Statement.>> judicial review, a regulation or order
issued under section 906, 907, 908, 909, 910, or 916 shall contain a
statement of the reasons for the issuance of such regulation or order in
the record of the proceedings held in connection with its issuance.
``SEC. 913. <<NOTE: Regulations. 21 USC 387m.>> EQUAL TREATMENT
OF RETAIL OUTLETS.
``The Secretary shall issue regulations to require that retail
establishments for which the predominant business is the sale of tobacco
products comply with any advertising restrictions applicable to retail
establishments accessible to individuals under the age of 18.
``SEC. 914. <<NOTE: 21 USC 387n.>> JURISDICTION OF AND
COORDINATION WITH THE FEDERAL TRADE
COMMISSION.
``(a) Jurisdiction.--
``(1) In general.--Except where expressly provided in this
chapter, nothing in this chapter shall be construed as limiting
or diminishing the authority of the Federal Trade Commission to
enforce the laws under its jurisdiction with respect to the
advertising, sale, or distribution of tobacco products.
``(2) Enforcement.--Any advertising that violates this
chapter or a provision of the regulations referred to in section
102 of the Family Smoking Prevention and Tobacco Control Act, is
an unfair or deceptive act or practice under section 5(a) of the
Federal Trade Commission Act and shall be considered a violation
of a rule promulgated under section 18 of that Act.
``(b) Coordination.--With respect to the requirements of section 4
of the Federal Cigarette Labeling and Advertising Act and section 3 of
the Comprehensive Smokeless Tobacco Health Education Act of 1986--
``(1) the Chairman of the Federal Trade Commission shall
coordinate with the Secretary concerning the enforcement of such
Act as such enforcement relates to unfair or deceptive acts or
practices in the advertising of cigarettes or smokeless tobacco;
and
``(2) the <<NOTE: Consultation.>> Secretary shall consult
with the Chairman of such Commission in revising the label
statements and requirements under such sections.
``SEC. 915. <<NOTE: 21 USC 387o.>> REGULATION REQUIREMENT.
``(a) Testing, Reporting, and Disclosure.--Not later than 36 months
after the date of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary shall promulgate regulations under this Act
that meet the requirements of subsection (b).
``(b) Contents of Rules.--The regulations promulgated under
subsection (a)--
``(1) shall require testing and reporting of tobacco product
constituents, ingredients, and additives, including smoke
constituents, by brand and subbrand that the Secretary
determines should be tested to protect the public health,
provided that, for purposes of the testing requirements of this
paragraph,
[[Page 123 STAT. 1821]]
tobacco products manufactured and sold by a single tobacco
product manufacturer that are identical in all respects except
the labels, packaging design, logo, trade dress, trademark,
brand name, or any combination thereof, shall be considered as a
single brand; and
``(2) may require that tobacco product manufacturers,
packagers, or importers make disclosures relating to the results
of the testing of tar and nicotine through labels or advertising
or other appropriate means, and make disclosures regarding the
results of the testing of other constituents, including smoke
constituents, ingredients, or additives, that the Secretary
determines should be disclosed to the public to protect the
public health and will not mislead consumers about the risk of
tobacco-related disease.
``(c) Authority.--The Secretary shall have the authority under this
chapter to conduct or to require the testing, reporting, or disclosure
of tobacco product constituents, including smoke constituents.
``(d) Small Tobacco Product Manufacturers.--
``(1) First compliance date.--The initial regulations
promulgated under subsection (a) shall not impose requirements
on small tobacco product manufacturers before the later of--
``(A) the end of the 2-year period following the
final promulgation of such regulations; and
``(B) the initial date set by the Secretary for
compliance with such regulations by manufacturers that
are not small tobacco product manufacturers.
``(2) Testing and reporting initial compliance period.--
``(A) 4-year period.--The initial regulations
promulgated under subsection (a) shall give each small
tobacco product manufacturer a 4-year period over which
to conduct testing and reporting for all of its tobacco
products. Subject to paragraph (1), the end of the first
year of such 4-year period shall coincide with the
initial date of compliance under this section set by the
Secretary with respect to manufacturers that are not
small tobacco product manufacturers or the end of the 2-
year period following the final promulgation of such
regulations, as described in paragraph (1)(A). A small
tobacco product manufacturer shall be required--
``(i) to conduct such testing and reporting
for 25 percent of its tobacco products during each
year of such 4-year period; and
``(ii) to conduct such testing and reporting
for its largest-selling tobacco products (as
determined by the Secretary) before its other
tobacco products, or in such other order of
priority as determined by the Secretary.
``(B) Case-by-case delay.--Notwithstanding
subparagraph (A), the Secretary may, on a case-by-case
basis, delay the date by which an individual small
tobacco product manufacturer must conduct testing and
reporting for its tobacco products under this section
based upon a showing of undue hardship to such
manufacturer. Notwithstanding the preceding sentence,
the Secretary shall not extend the deadline for a small
tobacco product manufacturer to conduct testing and
reporting for all of its tobacco products
[[Page 123 STAT. 1822]]
beyond a total of 5 years after the initial date of
compliance under this section set by the Secretary with
respect to manufacturers that are not small tobacco
product manufacturers.
``(3) Subsequent and additional testing and reporting.--The
regulations promulgated under subsection (a) shall provide that,
with respect to any subsequent or additional testing and
reporting of tobacco products required under this section, such
testing and reporting by a small tobacco product manufacturer
shall be conducted in accordance with the timeframes described
in paragraph (2)(A), except that, in the case of a new product,
or if there has been a modification described in section
910(a)(1)(B) of any product of a small tobacco product
manufacturer since the last testing and reporting required under
this section, the Secretary shall require that any subsequent or
additional testing and reporting be conducted in accordance with
the same timeframe applicable to manufacturers that are not
small tobacco product manufacturers.
``(4) Joint laboratory testing services.--The Secretary
shall allow any 2 or more small tobacco product manufacturers to
join together to purchase laboratory testing services required
by this section on a group basis in order to ensure that such
manufacturers receive access to, and fair pricing of, such
testing services.
``(e) Extensions for Limited Laboratory Capacity.--
``(1) In general.--The regulations promulgated under
subsection (a) shall provide that a small tobacco product
manufacturer shall not be considered to be in violation of this
section before the deadline applicable under paragraphs (3) and
(4), if--
``(A) the tobacco products of such manufacturer are
in compliance with all other requirements of this
chapter; and
``(B) the conditions described in paragraph (2) are
met.
``(2) Conditions.--Notwithstanding
the <<NOTE: Deadline. Evidence.>> requirements of this section,
the Secretary may delay the date by which a small tobacco
product manufacturer must be in compliance with the testing and
reporting required by this section until such time as the
testing is reported if, not later than 90 days before the
deadline for reporting in accordance with this section, a small
tobacco product manufacturer provides evidence to the Secretary
demonstrating that--
``(A) the manufacturer has submitted the required
products for testing to a laboratory and has done so
sufficiently in advance of the deadline to create a
reasonable expectation of completion by the deadline;
``(B) the products currently are awaiting testing by
the laboratory; and
``(C) neither that laboratory nor any other
laboratory is able to complete testing by the deadline
at customary, nonexpedited testing fees.
``(3) Extension.--The Secretary, taking into account the
laboratory testing capacity that is available to tobacco product
manufacturers, shall review and verify the evidence submitted by
a small tobacco product manufacturer in accordance with
paragraph (2). <<NOTE: Notification.>> If the Secretary finds
that the conditions described in such paragraph are met, the
Secretary shall notify
[[Page 123 STAT. 1823]]
the small tobacco product manufacturer that the manufacturer
shall not be considered to be in violation of the testing and
reporting requirements of this section until the testing is
reported or until 1 year after the reporting deadline has
passed, whichever occurs sooner. If, however, the Secretary has
not made a finding before the reporting deadline, the
manufacturer shall not be considered to be in violation of such
requirements until the Secretary finds that the conditions
described in paragraph (2) have not been met, or until 1 year
after the reporting deadline, whichever occurs sooner.
``(4) Additional extension.--In addition to the time that
may be provided under paragraph (3), the Secretary may provide
further extensions of time, in increments of no more than 1
year, for required testing and reporting to occur if the
Secretary determines, based on evidence properly and timely
submitted by a small tobacco product manufacturer in accordance
with paragraph (2), that a lack of available laboratory capacity
prevents the manufacturer from completing the required testing
during the period described in paragraph (3).
``(f) Rule of Construction.--Nothing in subsection (d) or (e) shall
be construed to authorize the extension of any deadline, or to otherwise
affect any timeframe, under any provision of this Act or the Family
Smoking Prevention and Tobacco Control Act other than this section.
``SEC. 916. <<NOTE: 21 USC 387p.>> PRESERVATION OF STATE AND
LOCAL AUTHORITY.
``(a) In General.--
``(1) Preservation.--Except as provided in paragraph (2)(A),
nothing in this chapter, or rules promulgated under this
chapter, shall be construed to limit the authority of a Federal
agency (including the Armed Forces), a State or political
subdivision of a State, or the government of an Indian tribe to
enact, adopt, promulgate, and enforce any law, rule, regulation,
or other measure with respect to tobacco products that is in
addition to, or more stringent than, requirements established
under this chapter, including a law, rule, regulation, or other
measure relating to or prohibiting the sale, distribution,
possession, exposure to, access to, advertising and promotion
of, or use of tobacco products by individuals of any age,
information reporting to the State, or measures relating to fire
safety standards for tobacco products. No provision of this
chapter shall limit or otherwise affect any State, tribal, or
local taxation of tobacco products.
``(2) Preemption of certain state and local requirements.--
``(A) In general.--No State or political subdivision
of a State may establish or continue in effect with
respect to a tobacco product any requirement which is
different from, or in addition to, any requirement under
the provisions of this chapter relating to tobacco
product standards, premarket review, adulteration,
misbranding, labeling, registration, good manufacturing
standards, or modified risk tobacco products.
``(B) Exception.--Subparagraph (A) does not apply to
requirements relating to the sale, distribution,
possession, information reporting to the State, exposure
to, access to, the advertising and promotion of, or use
of, tobacco products
[[Page 123 STAT. 1824]]
by individuals of any age, or relating to fire safety
standards for tobacco products. Information disclosed to
a State under subparagraph (A) that is exempt from
disclosure under section 552(b)(4) of title 5, United
States Code, shall be treated as a trade secret and
confidential information by the State.
``(b) Rule of Construction Regarding Product Liability.--No
provision of this chapter relating to a tobacco product shall be
construed to modify or otherwise affect any action or the liability of
any person under the product liability law of any State.
``SEC. 917. <<NOTE: 21 USC 387q.>> TOBACCO PRODUCTS SCIENTIFIC
ADVISORY COMMITTEE.
``(a) Establishment.--Not later <<NOTE: Deadline.>> than 6 months
after the date of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary shall establish a 12-member advisory
committee, to be known as the Tobacco Products Scientific Advisory
Committee (in this section referred to as the `Advisory Committee').
``(b) Membership.--
``(1) In general.--
``(A) Members.--The Secretary shall appoint as
members of the Tobacco Products Scientific Advisory
Committee individuals who are technically qualified by
training and experience in medicine, medical ethics,
science, or technology involving the manufacture,
evaluation, or use of tobacco products, who are of
appropriately diversified professional backgrounds. The
committee shall be composed of--
``(i) 7 individuals who are physicians,
dentists, scientists, or health care professionals
practicing in the area of oncology, pulmonology,
cardiology, toxicology, pharmacology, addiction,
or any other relevant specialty;
``(ii) 1 individual who is an officer or
employee of a State or local government or of the
Federal Government;
``(iii) 1 individual as a representative of
the general public;
``(iv) 1 individual as a representative of the
interests of the tobacco manufacturing industry;
``(v) 1 individual as a representative of the
interests of the small business tobacco
manufacturing industry, which position may be
filled on a rotating, sequential basis by
representatives of different small business
tobacco manufacturers based on areas of expertise
relevant to the topics being considered by the
Advisory Committee; and
``(vi) 1 individual as a representative of the
interests of the tobacco growers.
``(B) Nonvoting members.--The members of the
committee appointed under clauses (iv), (v), and (vi) of
subparagraph (A) shall serve as consultants to those
described in clauses (i) through (iii) of subparagraph
(A) and shall be nonvoting representatives.
``(C) Conflicts of interest.--No members of the
committee, other than members appointed pursuant to
clauses (iv), (v), and (vi) of subparagraph (A) shall,
during the member's tenure on the committee or for the
18-month
[[Page 123 STAT. 1825]]
period prior to becoming such a member, receive any
salary, grants, or other payments or support from any
business that manufactures, distributes, markets, or
sells cigarettes or other tobacco products.
``(2) Limitation.--The Secretary may not appoint to the
Advisory Committee any individual who is in the regular full-
time employ of the Food and Drug Administration or any agency
responsible for the enforcement of this Act. The Secretary may
appoint Federal officials as ex officio members.
``(3) Chairperson.--The Secretary shall designate 1 of the
members appointed under clauses (i), (ii), and (iii) of
paragraph (1)(A) to serve as chairperson.
``(c) Duties.--The Tobacco Products Scientific Advisory Committee
shall provide advice, information, and recommendations to the
Secretary--
``(1) as provided in this chapter;
``(2) on the effects of the alteration of the nicotine
yields from tobacco products;
``(3) on whether there is a threshold level below which
nicotine yields do not produce dependence on the tobacco product
involved; and
``(4) on its review of other safety, dependence, or health
issues relating to tobacco products as requested by the
Secretary.
``(d) Compensation; Support; FACA.--
``(1) Compensation and travel.--Members of the Advisory
Committee who are not officers or employees of the United
States, while attending conferences or meetings of the committee
or otherwise engaged in its business, shall be entitled to
receive compensation at rates to be fixed by the Secretary,
which may not exceed the daily equivalent of the rate in effect
under the Senior Executive Schedule under section 5382 of title
5, United States Code, for each day (including travel time) they
are so engaged; and while so serving away from their homes or
regular places of business each member may be allowed travel
expenses, including per diem in lieu of subsistence, as
authorized by section 5703 of title 5, United States Code, for
persons in the Government service employed intermittently.
``(2) Administrative support.--The Secretary shall furnish
the Advisory Committee clerical and other assistance.
``(3) Nonapplication of faca.--Section 14 of the Federal
Advisory Committee Act does not apply to the Advisory Committee.
``(e) <<NOTE: Records.>> Proceedings of Advisory Panels and
Committees.--The Advisory Committee shall make and maintain a transcript
of any proceeding of the panel or committee. Each such panel and
committee shall delete from any transcript made under this subsection
information which is exempt from disclosure under section 552(b) of
title 5, United States Code.
``SEC. 918. <<NOTE: 21 USC 387r.>> DRUG PRODUCTS USED TO TREAT
TOBACCO DEPENDENCE.
``(a) In General.--The Secretary shall--
``(1) at the request of the applicant, consider designating
products for smoking cessation, including nicotine replacement
products as fast track research and approval products within the
meaning of section 506;
[[Page 123 STAT. 1826]]
``(2) consider approving the extended use of nicotine
replacement products (such as nicotine patches, nicotine gum,
and nicotine lozenges) for the treatment of tobacco dependence;
and
``(3) review and consider the evidence for additional
indications for nicotine replacement products, such as for
craving relief or relapse prevention.
``(b) Report on Innovative Products.--
``(1) In general.--Not later than 3 years after the date of
enactment of the Family Smoking Prevention and Tobacco Control
Act, the Secretary, after consultation with recognized
scientific, medical, and public health experts (including both
Federal agencies and nongovernmental entities, the Institute of
Medicine of the National Academy of Sciences, and the Society
for Research on Nicotine and Tobacco), shall submit to the
Congress a report that examines how best to regulate, promote,
and encourage the development of innovative products and
treatments (including nicotine-based and non-nicotine-based
products and treatments) to better achieve, in a manner that
best protects and promotes the public health--
``(A) total abstinence from tobacco use;
``(B) reductions in consumption of tobacco; and
``(C) reductions in the harm associated with
continued tobacco use.
``(2) Recommendations.--The report under paragraph (1) shall
include the recommendations of the Secretary on how the Food and
Drug Administration should coordinate and facilitate the
exchange of information on such innovative products and
treatments among relevant offices and centers within the
Administration and within the National Institutes of Health, the
Centers for Disease Control and Prevention, and other relevant
agencies.
``SEC. 919. <<NOTE: 21 USC 387s.>> USER FEES.
``(a) Establishment of Quarterly Fee.--Beginning
on <<NOTE: Effective date.>> the date of enactment of the Family
Smoking Prevention and Tobacco Control Act, the Secretary shall in
accordance with this section assess user fees on, and collect such fees
from, each manufacturer and importer of tobacco products subject to this
chapter. The fees shall be assessed and collected with respect to each
quarter of each fiscal year, and the total amount assessed and collected
for a fiscal year shall be the amount specified in subsection (b)(1) for
such year, subject to subsection (c).
``(b) Assessment of User Fee.--
``(1) Amount of assessment.--The total amount of user fees
authorized to be assessed and collected under subsection (a) for
a fiscal year is the following, as applicable to the fiscal year
involved:
``(A) For fiscal year 2009, $85,000,000 (subject to
subsection (e)).
``(B) For fiscal year 2010, $235,000,000.
``(C) For fiscal year 2011, $450,000,000.
``(D) For fiscal year 2012, $477,000,000.
``(E) For fiscal year 2013, $505,000,000.
``(F) For fiscal year 2014, $534,000,000.
``(G) For fiscal year 2015, $566,000,000.
``(H) For fiscal year 2016, $599,000,000.
[[Page 123 STAT. 1827]]
``(I) For fiscal year 2017, $635,000,000.
``(J) For fiscal year 2018, $672,000,000.
``(K) For fiscal year 2019 and each subsequent
fiscal year, $712,000,000.
``(2) Allocations of assessment by class of tobacco
products.--
``(A) In general.--The total user fees assessed and
collected under subsection (a) each fiscal year with
respect to each class of tobacco products shall be an
amount that is equal to the applicable percentage of
each class for the fiscal year multiplied by the amount
specified in paragraph (1) for the fiscal year.
``(B) Applicable percentage.--
``(i) In general.--For purposes of
subparagraph (A), the applicable percentage for a
fiscal year for each of the following classes of
tobacco products shall be determined in accordance
with clause (ii):
``(I) Cigarettes.
``(II) Cigars, including small
cigars and cigars other than small
cigars.
``(III) Snuff.
``(IV) Chewing tobacco.
``(V) Pipe tobacco.
``(VI) Roll-your-own tobacco.
``(ii) Allocations.--The applicable percentage
of each class of tobacco product described in
clause (i) for a fiscal year shall be the
percentage determined under section 625(c) of
Public Law 108-357 for each such class of product
for such fiscal year.
``(iii) Requirement of regulations.--
Notwithstanding clause (ii), no user fees shall be
assessed on a class of tobacco products unless
such class of tobacco products is listed in
section 901(b) or is deemed by the Secretary in a
regulation under section 901(b) to be subject to
this chapter.
``(iv) Reallocations.--In the case of a class
of tobacco products that is not listed in section
901(b) or deemed by the Secretary in a regulation
under section 901(b) to be subject to this
chapter, the amount of user fees that would
otherwise be assessed to such class of tobacco
products shall be reallocated to the classes of
tobacco products that are subject to this chapter
in the same manner and based on the same relative
percentages otherwise determined under clause
(ii).
``(3) Determination of user fee by company.--
``(A) In general.--The total user fee to be paid by
each manufacturer or importer of a particular class of
tobacco products shall be determined for each quarter by
multiplying--
``(i) such manufacturer's or importer's
percentage share as determined under paragraph
(4); by
``(ii) the portion of the user fee amount for
the current quarter to be assessed on all
manufacturers and importers of such class of
tobacco products as determined under paragraph
(2).
[[Page 123 STAT. 1828]]
``(B) No fee in excess of percentage share.--No
manufacturer or importer of tobacco products shall be
required to pay a user fee in excess of the percentage
share of such manufacturer or importer.
``(4) Allocation of assessment within each class of tobacco
product.--The percentage share of each manufacturer or importer
of a particular class of tobacco products of the total user fee
to be paid by all manufacturers or importers of that class of
tobacco products shall be the percentage determined for purposes
of allocations under subsections (e) through (h) of section 625
of Public Law 108-357.
``(5) Allocation for cigars.--Notwithstanding paragraph (4),
if a user fee assessment is imposed on cigars, the percentage
share of each manufacturer or importer of cigars shall be based
on the excise taxes paid by such manufacturer or importer during
the prior fiscal year.
``(6) Timing of assessment.--The
Secretary <<NOTE: Notification.>> shall notify each
manufacturer and importer of tobacco products subject to this
section of the amount of the quarterly assessment imposed on
such manufacturer or importer under this subsection for each
quarter of each fiscal year. <<NOTE: Deadlines.>> Such
notifications shall occur not later than 30 days prior to the
end of the quarter for which such assessment is made, and
payments of all assessments shall be made by the last day of the
quarter involved.
``(7) Memorandum of understanding.--
``(A) In general.--The Secretary shall request the
appropriate Federal agency to enter into a memorandum of
understanding that provides for the regular and timely
transfer from the head of such agency to the Secretary
of the information described in paragraphs (2)(B)(ii)
and (4) and all necessary information regarding all
tobacco product manufacturers and importers required to
pay user fees. <<NOTE: Disclosure.>> The Secretary
shall maintain all disclosure restrictions established
by the head of such agency regarding the information
provided under the memorandum of understanding.
``(B) Assurances.--Beginning not <<NOTE: Effective
dates.>> later than fiscal year 2015, and for each
subsequent fiscal year, the Secretary shall ensure that
the Food and Drug Administration is able to determine
the applicable percentages described in paragraph (2)
and the percentage shares described in paragraph (4).
The Secretary may carry out this subparagraph by
entering into a contract with the head of the Federal
agency referred to in subparagraph (A) to continue to
provide the necessary information.
``(c) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts, subject to paragraph (2)(D). Such fees are authorized to
remain available until expended. Such sums as may be necessary
may be transferred from the Food and Drug Administration
salaries and expenses appropriation account without fiscal year
limitation to such appropriation account for salaries and
expenses with such fiscal year limitation.
``(2) Availability.--
[[Page 123 STAT. 1829]]
``(A) In general.--Fees appropriated under paragraph
(3) are available only for the purpose of paying the
costs of the activities of the Food and Drug
Administration related to the regulation of tobacco
products under this chapter and the Family Smoking
Prevention and Tobacco Control Act (referred to in this
subsection as `tobacco regulation activities'), except
that such fees may be used for the reimbursement
specified in subparagraph (C).
``(B) Prohibition against use of other funds.--
``(i) In general.--Except as provided in
clause (ii), fees collected under subsection (a)
are the only funds authorized to be made available
for tobacco regulation activities.
``(ii) Startup costs.--Clause
(i) <<NOTE: Effective date.>> does not apply
until October 1, 2009. Until such date, any
amounts available to the Food and Drug
Administration (excluding user fees) shall be
available and allocated as needed to pay the costs
of tobacco regulation activities.
``(C) Reimbursement of start-up amounts.--
``(i) In general.--Any amounts allocated for
the start-up period pursuant to subparagraph
(B)(ii) shall be reimbursed through any
appropriated fees collected under subsection (a),
in such manner as the Secretary determines
appropriate to ensure that such allocation results
in no net change in the total amount of funds
otherwise available, for the period from October
1, 2008, through September 30, 2010, for Food and
Drug Administration programs and activities (other
than tobacco regulation activities) for such
period.
``(ii) <<NOTE: Deadline.>> Treatment of
reimbursed amounts.--Amounts reimbursed under
clause (i) shall be available for the programs and
activities for which funds allocated for the
start-up period were available, prior to such
allocation, until September 30, 2010,
notwithstanding any otherwise applicable limits on
amounts for such programs or activities for a
fiscal year.
``(D) <<NOTE: Deadline.>> Fee collected during
start-up period.--Notwithstanding the first sentence of
paragraph (1), fees under subsection (a) may be
collected through September 30, 2009 under subparagraph
(B)(ii) and shall be available for obligation and remain
available until expended. Such offsetting collections
shall be credited to the salaries and expenses account
of the Food and Drug Administration.
``(E) Obligation of start-up costs in anticipation
of available fee collections.--Notwithstanding any other
provision of law, following the enactment of an
appropriation for fees under this section for fiscal
year 2010, or any portion thereof, obligations for costs
of tobacco regulation activities during the start-up
period may be incurred in anticipation of the receipt of
offsetting fee collections through procedures specified
in section 1534 of title 31, United States Code.
``(3) Authorization of appropriations.--For fiscal year 2009
and each subsequent fiscal year, there is authorized to be
appropriated for fees under this section an amount equal to the
amount specified in subsection (b)(1) for the fiscal year.
[[Page 123 STAT. 1830]]
``(d) Collection of Unpaid Fees.--In any <<NOTE: Deadline.>> case
where the Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall be treated
as a claim of the United States Government subject to subchapter II of
chapter 37 of title 31, United States Code.
``(e) Applicability to Fiscal Year 2009.--If the date of enactment
of the Family Smoking Prevention and Tobacco Control Act occurs during
fiscal year 2009, the following applies, subject to subsection (c):
``(1) The <<NOTE: Fees.>> Secretary shall determine the
fees that would apply for a single quarter of such fiscal year
according to the application of subsection (b) to the amount
specified in paragraph (1)(A) of such subsection (referred to in
this subsection as the `quarterly fee amounts').
``(2) For the quarter in which such date of enactment
occurs, the amount of fees assessed shall be a pro rata amount,
determined according to the number of days remaining in the
quarter (including such date of enactment) and according to the
daily equivalent of the quarterly fee amounts. Fees assessed
under the preceding sentence shall not be collected until the
next quarter.
``(3) For the quarter following the quarter to which
paragraph (2) applies, the full quarterly fee amounts shall be
assessed and collected, in addition to collection of the pro
rata fees assessed under paragraph (2).''.
(c) Conforming Amendment.--Section 9(1) of the Comprehensive
Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4408(i)) is
amended to read as follows:
``(1) The term `smokeless tobacco' has the meaning given
such term by section 900(18) of the Federal Food, Drug, and
Cosmetic Act.''.
SEC. 102. <<NOTE: 21 USC 387a-1.>> FINAL RULE.
(a) Cigarettes and Smokeless Tobacco.--
(1) In general.--On the <<NOTE: Deadline. Federal Register,
publication.>> first day of publication of the Federal Register
that is 180 days or more after the date of enactment of this
Act, the Secretary of Health and Human Services shall publish in
the Federal Register a final rule regarding cigarettes and
smokeless tobacco, which--
(A) is deemed to be issued under chapter 9 of the
Federal Food, Drug, and Cosmetic Act, as added by
section 101 of this division; and
(B) shall be deemed to be in compliance with all
applicable provisions of chapter 5 of title 5, United
States Code, and all other provisions of law relating to
rulemaking procedures.
(2) Contents of rule.--Except as provided in this
subsection, the final rule published under paragraph (1), shall
be identical in its provisions to part 897 of the regulations
promulgated by the Secretary of Health and Human Services in the
August 28, 1996, issue of the Federal Register (61 Fed. Reg.
44615-44618). Such rule shall--
(A) provide for the designation of jurisdictional
authority that is in accordance with this subsection in
accordance with this division and the amendments made by
this division;
(B) strike Subpart C--Labels and section 897.32(c);
[[Page 123 STAT. 1831]]
(C) strike paragraphs (a), (b), and (i) of section
897.3 and insert definitions of the terms ``cigarette'',
``cigarette tobacco'', and ``smokeless tobacco'' as
defined in section 900 of the Federal Food, Drug, and
Cosmetic Act;
(D) insert ``or roll-your-own paper'' in section
897.34(a) after ``other than cigarettes or smokeless
tobacco'';
(E) include such modifications to section 897.30(b),
if any, that the Secretary determines are appropriate in
light of governing First Amendment case law, including
the decision of the Supreme Court of the United States
in Lorillard Tobacco Co. v. Reilly (533 U.S. 525
(2001));
(F) become <<NOTE: Effective date.>> effective on
the date that is 1 year after the date of enactment of
this Act; and
(G) amend paragraph (d) of section 897.16 to read as
follows:
``(d)(1) Except as provided in subparagraph (2), no manufacturer,
distributor, or retailer may distribute or cause to be distributed any
free samples of cigarettes, smokeless tobacco, or other tobacco products
(as such term is defined in section 201 of the Federal Food, Drug, and
Cosmetic Act).
``(2)(A) Subparagraph (1) does not prohibit a manufacturer,
distributor, or retailer from distributing or causing to be distributed
free samples of smokeless tobacco in a qualified adult-only facility.
``(B) This subparagraph does not affect the authority of a State or
local government to prohibit or otherwise restrict the distribution of
free samples of smokeless tobacco.
``(C) For purposes of this paragraph, the term `qualified adult-only
facility' means a facility or restricted area that--
``(i) requires each person present to provide to a law
enforcement officer (whether on or off duty) or to a security
guard licensed by a governmental entity government-issued
identification showing a photograph and at least the minimum age
established by applicable law for the purchase of smokeless
tobacco;
``(ii) does not sell, serve, or distribute alcohol;
``(iii) is not located adjacent to or immediately across
from (in any direction) a space that is used primarily for
youth-oriented marketing, promotional, or other activities;
``(iv) is a temporary structure constructed, designated, and
operated as a distinct enclosed area for the purpose of
distributing free samples of smokeless tobacco in accordance
with this subparagraph;
``(v) is enclosed by a barrier that--
``(I) is constructed of, or covered with, an opaque
material (except for entrances and exits);
``(II) extends from no more than 12 inches above the
ground or floor (which area at the bottom of the barrier
must be covered with material that restricts visibility
but may allow airflow) to at least 8 feet above the
ground or floor (or to the ceiling); and
``(III) prevents persons outside the qualified
adult-only facility from seeing into the qualified
adult-only facility, unless they make unreasonable
efforts to do so; and
``(vi) does not display on its exterior--
``(I) any tobacco product advertising;
[[Page 123 STAT. 1832]]
``(II) a brand name other than in conjunction with
words for an area or enclosure to identify an adult-only
facility; or
``(III) any combination of words that would imply to
a reasonable observer that the manufacturer,
distributor, or retailer has a sponsorship that would
violate section 897.34(c).
``(D) Distribution of samples of smokeless tobacco under this
subparagraph permitted to be taken out of the qualified adult-only
facility shall be limited to 1 package per adult consumer containing no
more than 0.53 ounces (15 grams) of smokeless tobacco. If such package
of smokeless tobacco contains individual portions of smokeless tobacco,
the individual portions of smokeless tobacco shall not exceed 8
individual portions and the collective weight of such individual
portions shall not exceed 0.53 ounces (15 grams). Any manufacturer,
distributor, or retailer who distributes or causes to be distributed
free samples also shall take reasonable steps to ensure that the above
amounts are limited to one such package per adult consumer per day.
``(3) Notwithstanding subparagraph (2), no manufacturer,
distributor, or retailer may distribute or cause to be distributed any
free samples of smokeless tobacco--
``(A) to a sports team or entertainment group; or
``(B) at any football, basketball, baseball, soccer, or
hockey event or any other sporting or entertainment event
determined by the Secretary to be covered by this subparagraph.
``(4) The <<NOTE: Reports. Deadline.>> Secretary shall implement a
program to ensure compliance with this paragraph and submit a report to
the Congress on such compliance not later than 18 months after the date
of enactment of the Family Smoking Prevention and Tobacco Control Act.
``(5) Nothing in this paragraph shall be construed to authorize any
person to distribute or cause to be distributed any sample of a tobacco
product to any individual who has not attained the minimum age
established by applicable law for the purchase of such product.''.
(3) Amendments to rule.--Prior to making amendments to the
rule published under paragraph (1), the Secretary shall
promulgate a proposed rule in accordance with chapter 5 of title
5, United States Code.
(4) Rule of construction.--Except as provided in paragraph
(3), nothing in this section shall be construed to limit the
authority of the Secretary to amend, in accordance with chapter
5 of title 5, United States Code, the regulation promulgated
pursuant to this section, including the provisions of such
regulation relating to distribution of free samples.
(5) Enforcement of retail sale provisions.--The Secretary of
Health and Human Services shall ensure that the provisions of
this division, the amendments made by this division, and the
implementing regulations (including such provisions, amendments,
and regulations relating to the retail sale of tobacco products)
are enforced with respect to the United States and Indian
tribes.
(6) Qualified adult-only facility.--A
qualified <<NOTE: Penalties.>> adult-only facility (as such
term is defined in section 897.16(d) of the final rule published
under paragraph (1)) that is also a retailer and that commits a
violation as a retailer shall not
[[Page 123 STAT. 1833]]
be subject to the limitations in section 103(q) and shall be
subject to penalties applicable to a qualified adult-only
facility.
(7) Congressional review provisions.--Section 801 of title
5, United States Code, shall not apply to the final rule
published under paragraph (1).
(b) Limitation on Advisory Opinions.--As of the date of enactment of
this Act, the following documents issued by the Food and Drug
Administration shall not constitute advisory opinions under section
10.85(d)(1) of title 21, Code of Federal Regulations, except as they
apply to tobacco products, and shall not be cited by the Secretary of
Health and Human Services or the Food and Drug Administration as binding
precedent:
(1) The preamble to the proposed rule in the document titled
``Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco Products to Protect Children
and Adolescents'' (60 Fed. Reg. 41314-41372 (August 11, 1995)).
(2) The document titled ``Nicotine in Cigarettes and
Smokeless Tobacco Products is a Drug and These Products Are
Nicotine Delivery Devices Under the Federal Food, Drug, and
Cosmetic Act'' (60 Fed. Reg. 41453-41787 (August 11, 1995)).
(3) The preamble to the final rule in the document titled
``Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco to Protect Children and
Adolescents'' (61 Fed. Reg. 44396-44615 (August 28, 1996)).
(4) The document titled ``Nicotine in Cigarettes and
Smokeless Tobacco is a Drug and These Products are Nicotine
Delivery Devices Under the Federal Food, Drug, and Cosmetic Act;
Jurisdictional Determination'' (61 Fed. Reg. 44619-45318 (August
28, 1996)).
SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS.
(a) Amendment of Federal Food, Drug, and Cosmetic Act.--Except as
otherwise expressly provided, whenever in this section an amendment is
expressed in terms of an amendment to, or repeal of, a section or other
provision, the reference is to a section or other provision of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
(1) in subsection (a), by inserting ``tobacco product,''
after ``device,'';
(2) in subsection (b), by inserting ``tobacco product,''
after ``device,'';
(3) in subsection (c), by inserting ``tobacco product,''
after ``device,'';
(4) in subsection (e)--
(A) by striking the period after ``572(i)''; and
(B) by striking ``or 761 or the refusal to permit
access to'' and inserting ``761, 909, or 920 or the
refusal to permit access to'';
(5) in subsection (g), by inserting ``tobacco product,''
after ``device,'';
(6) in subsection (h), by inserting ``tobacco product,''
after ``device,'';
(7) in subsection (j)--
(A) by striking the period after ``573''; and
[[Page 123 STAT. 1834]]
(B) by striking ``708, or 721'' and inserting ``708,
721, 904, 905, 906, 907, 908, 909, or 920(b)'';
(8) in subsection (k), by inserting ``tobacco product,''
after ``device,'';
(9) by striking subsection (p) and inserting the following:
``(p) The failure to register in accordance with section 510 or 905,
the failure to provide any information required by section 510(j),
510(k), 905(i), or 905(j), or the failure to provide a notice required
by section 510(j)(2) or 905(i)(3).'';
(10) by striking subsection (q)(1) and inserting the
following:
``(q)(1) The failure or refusal--
``(A) to comply with any requirement prescribed under
section 518, 520(g), 903(b), 907, 908, or 915;
``(B) to furnish any notification or other material or
information required by or under section 519, 520(g), 904, 909,
or 920; or
``(C) to comply with a requirement under section 522 or
913.'';
(11) in subsection (q)(2), by striking ``device,'' and
inserting ``device or tobacco product,'';
(12) in subsection (r), by inserting ``or tobacco product''
after the term ``device'' each time that such term appears; and
(13) by adding at the end the following:
``(oo) The sale of tobacco products in violation of a no-tobacco-
sale order issued under section 303(f).
``(pp) The introduction or delivery for introduction into interstate
commerce of a tobacco product in violation of section 911.
``(qq)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark, stamp
(including tax stamp), tag, label, or other identification device upon
any tobacco product or container or labeling thereof so as to render
such tobacco product a counterfeit tobacco product.
``(2) Making, selling, disposing of, or keeping in possession,
control, or custody, or concealing any punch, die, plate, stone, or
other item that is designed to print, imprint, or reproduce the
trademark, trade name, or other identifying mark, imprint, or device of
another or any likeness of any of the foregoing upon any tobacco product
or container or labeling thereof so as to render such tobacco product a
counterfeit tobacco product.
``(3) The doing of any act that causes a tobacco product to be a
counterfeit tobacco product, or the sale or dispensing, or the holding
for sale or dispensing, of a counterfeit tobacco product.
``(rr) The charitable distribution of tobacco products.
``(ss) The failure of a manufacturer or distributor to notify the
Attorney General and the Secretary of the Treasury of their knowledge of
tobacco products used in illicit trade.
``(tt) Making any express or implied statement or representation
directed to consumers with respect to a tobacco product, in a label or
labeling or through the media or advertising, that either conveys, or
misleads or would mislead consumers into believing, that--
``(1) the product is approved by the Food and Drug
Administration;
``(2) the Food and Drug Administration deems the product to
be safe for use by consumers;
[[Page 123 STAT. 1835]]
``(3) the product is endorsed by the Food and Drug
Administration for use by consumers; or
``(4) the product is safe or less harmful by virtue of--
``(A) its regulation or inspection by the Food and
Drug Administration; or
``(B) its compliance with regulatory requirements
set by the Food and Drug Administration;
including any such statement or representation rendering the
product misbranded under section 903.''.
(c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is amended--
(1) in paragraph (5)--
(A) by striking ``paragraph (1), (2), (3), or (4)''
each place such appears and inserting ``paragraph (1),
(2), (3), (4), or (9)'';
(B) in subparagraph (A)--
(i) by striking ``assessed'' the first time it
appears and inserting ``assessed, or a no-tobacco-
sale order may be imposed,''; and
(ii) by striking ``penalty'' the second time
it appears and inserting ``penalty, or upon whom a
no-tobacco-sale order is to be imposed,'';
(C) in subparagraph (B)--
(i) by inserting after ``penalty,'' the
following: ``or the period to be covered by a no-
tobacco-sale order,''; and
(ii) by adding at the end the following: ``A
no-tobacco-sale order permanently prohibiting an
individual retail outlet from selling tobacco
products shall include provisions that allow the
outlet, after a specified period of time, to
request that the Secretary compromise, modify, or
terminate the order.''; and
(D) by adding at the end the following:
``(D) The Secretary may compromise, modify, or terminate, with or
without conditions, any no-tobacco-sale order.'';
(2) in paragraph (6)--
(A) by inserting ``or the imposition of a no-
tobacco-sale order'' after the term ``penalty'' each
place such term appears; and
(B) by striking ``issued.'' and inserting ``issued,
or on which the no-tobacco-sale order was imposed, as
the case may be.''; and
(3) by adding at the end the following:
``(8) If the Secretary finds that a person has committed repeated
violations of restrictions promulgated under section 906(d) at a
particular retail outlet then the Secretary may impose a no-tobacco-sale
order on that person prohibiting the sale of tobacco products in that
outlet. A no-tobacco-sale order may be imposed with a civil penalty
under paragraph (1). Prior to the entry of a no-sale order under this
paragraph, a person shall be entitled to a hearing pursuant to the
procedures established through regulations of the Food and Drug
Administration for assessing civil money penalties, including at a
retailer's request a hearing by telephone, or at the nearest regional or
field office of the Food and Drug Administration, or at a Federal,
State, or county facility within 100 miles from the location of the
retail outlet, if such a facility is available.
[[Page 123 STAT. 1836]]
``(9) Civil Monetary Penalties for Violation of Tobacco Product
Requirements.--
``(A) In general.--Subject to subparagraph (B), any person
who violates a requirement of this Act which relates to tobacco
products shall be liable to the United States for a civil
penalty in an amount not to exceed $15,000 for each such
violation, and not to exceed $1,000,000 for all such violations
adjudicated in a single proceeding.
``(B) Enhanced penalties.--
``(i) Any person who intentionally violates a
requirement of section 902(5), 902(6), 904, 908(c), or
911(a), shall be subject to a civil monetary penalty
of--
``(I) not to exceed $250,000 per violation,
and not to exceed $1,000,000 for all such
violations adjudicated in a single proceeding; or
``(II) in <<NOTE: Notice.>> the case of a
violation that continues after the Secretary
provides written notice to such person, $250,000
for the first 30-day period (or any portion
thereof) that the person continues to be in
violation, and such amount shall double for every
30-day period thereafter that the violation
continues, not to exceed $1,000,000 for any 30-day
period, and not to exceed $10,000,000 for all such
violations adjudicated in a single proceeding.
``(ii) Any person who violates a requirement of
section 911(g)(2)(C)(ii) or 911(i)(1), shall be subject
to a civil monetary penalty of--
``(I) not to exceed $250,000 per violation,
and not to exceed $1,000,000 for all such
violations adjudicated in a single proceeding; or
``(II) in <<NOTE: Notice.>> the case of a
violation that continues after the Secretary
provides written notice to such person, $250,000
for the first 30-day period (or any portion
thereof) that the person continues to be in
violation, and such amount shall double for every
30-day period thereafter that the violation
continues, not to exceed $1,000,000 for any 30-day
period, and not to exceed $10,000,000 for all such
violations adjudicated in a single proceeding.
``(iii) In determining the amount of a civil penalty
under clause (i)(II) or (ii)(II), the Secretary shall
take into consideration whether the person is making
efforts toward correcting the violation of the
requirements of the section for which such person is
subject to such civil penalty.''.
(d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
(1) in subsection (a)(2)--
(A) by striking ``and'' before ``(D)''; and
(B) by striking ``device.'' and inserting the
following: ``device, and (E) Any adulterated or
misbranded tobacco product.'';
(2) in subsection (d)(1), by inserting ``tobacco product,''
after ``device,'';
(3) in subsection (g)(1), by inserting ``or tobacco
product'' after the term ``device'' each place such term
appears; and
(4) in subsection (g)(2)(A), by inserting ``or tobacco
product'' after ``device''.
[[Page 123 STAT. 1837]]
(e) Section 505.--Section 505(n)(2) (21 U.S.C. 355(n)(2)) is amended
by striking ``section 904'' and inserting ``section 1004''.
(f) Section 523.--Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) is
amended by striking ``section 903(g)'' and inserting ``section
1003(g)''.
(g) Section 702.--Section 702(a)(1) (U.S.C. 372(a)(1)) <<NOTE: 21
USC 372.>> is amended--
(1) by striking ``(a)(1)'' and inserting ``(a)(1)(A)''; and
(2) by adding at the end the following:
``(B)(i) For <<NOTE: Contracts. Inter- governmental relations.>> a
tobacco product, to the extent feasible, the Secretary shall contract
with the States in accordance with this paragraph to carry out
inspections of retailers within that State in connection with the
enforcement of this Act.
``(ii) The Secretary shall not enter into any contract under clause
(i) with the government of any of the several States to exercise
enforcement authority under this Act on Indian country without the
express written consent of the Indian tribe involved.''.
(h) Section 703.--Section 703 (21 U.S.C. 373) is amended--
(1) by inserting ``tobacco product,'' after the term
``device,'' each place such term appears; and
(2) by inserting ``tobacco products,'' after the term
``devices,'' each place such term appears.
(i) Section 704.--Section 704 (21 U.S.C. 374) is amended--
(1) in subsection (a)(1)--
(A) by striking ``devices, or cosmetics'' each place
it appears and inserting ``devices, tobacco products, or
cosmetics'';
(B) by striking ``or restricted devices'' each place
it appears and inserting ``restricted devices, or
tobacco products''; and
(C) by striking ``and devices and subject to'' and
all that follows through ``other drugs or devices'' and
inserting ``devices, and tobacco products and subject to
reporting and inspection under regulations lawfully
issued pursuant to section 505 (i) or (k), section 519,
section 520(g), or chapter IX and data relating to other
drugs, devices, or tobacco products'';
(2) in subsection (b), by inserting ``tobacco product,''
after ``device,''; and
(3) in subsection (g)(13), by striking ``section 903(g)''
and inserting ``section 1003(g)''.
(j) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is amended by
inserting ``tobacco products,'' after ``devices,''.
(k) Section 709.--Section 709 (21 U.S.C. 379a) is amended by
inserting ``tobacco product,'' after ``device,''.
(l) Section 801.--Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (a)--
(A) by inserting ``tobacco products,'' after the
term ``devices,'';
(B) by inserting ``or section 905(h)'' after
``section 510''; and
(C) by striking the term ``drugs or devices'' each
time such term appears and inserting ``drugs, devices,
or tobacco products'';
(2) in subsection (e)(1)--
(A) by inserting ``tobacco product'' after ``drug,
device,''; and
[[Page 123 STAT. 1838]]
(B) by inserting ``, and a tobacco product intended
for export shall not be deemed to be in violation of
section 906(e), 907, 911, or 920(a),'' before ``if it--
''; and
(3) by adding at the end the following:
``(p)(1) Not <<NOTE: Deadline. Reports.>> later than 36 months
after the date of enactment of the Family Smoking Prevention and Tobacco
Control Act, and annually thereafter, the Secretary shall submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives, a
report regarding--
``(A) the nature, extent, and destination of United States
tobacco product exports that do not conform to tobacco product
standards established pursuant to this Act;
``(B) the public health implications of such exports,
including any evidence of a negative public health impact; and
``(C) recommendations or assessments of policy alternatives
available to Congress and the executive branch to reduce any
negative public health impact caused by such exports.
``(2) The <<NOTE: Requirements.>> Secretary is authorized to
establish appropriate information disclosure requirements to carry out
this subsection.''.
(m) Section 1003.--Section 1003(d)(2)(C) (as redesignated by section
101(b)) <<NOTE: 21 USC 393.>> is amended--
(1) by striking ``and'' after ``cosmetics,''; and
(2) inserting ``, and tobacco products'' after ``devices''.
(n) Section 1009.--Section 1009(b) (as redesignated by section
101(b)) is <<NOTE: 21 USC 399.>> amended by striking ``section 908''
and inserting ``section 1008''.
(o) Section 409 of the Federal Meat Inspection Act.--Section 409(a)
of the Federal Meat Inspection Act (21 U.S.C. 679(a)) is amended by
striking ``section 902(b)'' and inserting ``section 1002(b)''.
(p) <<NOTE: 21 USC 331 note.>> Rule of Construction.--Nothing in
this section is intended or shall be construed to expand, contract, or
otherwise modify or amend the existing limitations on State government
authority over tribal restricted fee or trust lands.
(q) Guidance and Effective Dates.--
(1) <<NOTE: 21 USC 333 note.>> In general.--The Secretary
of Health and Human Services shall issue guidance--
(A) defining the term ``repeated violation'', as
used in section 303(f)(8) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by
subsection (c), as including at least 5 violations of
particular requirements over a 36-month period at a
particular retail outlet that constitute a repeated
violation and providing for civil penalties in
accordance with paragraph (2);
(B) providing for timely and effective notice by
certified or registered mail or personal delivery to the
retailer of each alleged violation at a particular
retail outlet prior to conducting a followup compliance
check, such notice to be sent to the location specified
on the retailer's registration or to the retailer's
registered agent if the retailer has provider such agent
information to the Food and Drug Administration prior to
the violation;
(C) providing for a hearing pursuant to the
procedures established through regulations of the Food
and Drug Administration for assessing civil money
penalties,
[[Page 123 STAT. 1839]]
including at a retailer's request a hearing by telephone
or at the nearest regional or field office of the Food
and Drug Administration, and providing for an expedited
procedure for the administrative appeal of an alleged
violation;
(D) providing that a person may not be charged with
a violation at a particular retail outlet unless the
Secretary has provided notice to the retailer of all
previous violations at that outlet;
(E) establishing that civil money penalties for
multiple violations shall increase from one violation to
the next violation pursuant to paragraph (2) within the
time periods provided for in such paragraph;
(F) providing that good faith reliance on the
presentation of a false government-issued photographic
identification that contains a date of birth does not
constitute a violation of any minimum age requirement
for the sale of tobacco products if the retailer has
taken effective steps to prevent such violations,
including--
(i) adopting and enforcing a written policy
against sales to minors;
(ii) informing its employees of all applicable
laws;
(iii) establishing disciplinary sanctions for
employee noncompliance; and
(iv) requiring its employees to verify age by
way of photographic identification or electronic
scanning device; and
(G) providing for the Secretary, in determining
whether to impose a no-tobacco-sale order and in
determining whether to compromise, modify, or terminate
such an order, to consider whether the retailer has
taken effective steps to prevent violations of the
minimum age requirements for the sale of tobacco
products, including the steps listed in subparagraph
(F).
(2) <<NOTE: 21 USC 333 note.>> Penalties for violations.--
(A) In general.--The amount of the civil penalty to
be applied for violations of restrictions promulgated
under section 906(d), as described in paragraph (1),
shall be as follows:
(i) With respect to a retailer with an
approved training program, the amount of the civil
penalty shall not exceed--
(I) in the case of the first
violation, $0.00 together with the
issuance of a warning letter to the
retailer;
(II) in the case of a second
violation within a 12-month period,
$250;
(III) in the case of a third
violation within a 24-month period,
$500;
(IV) in the case of a fourth
violation within a 24-month period,
$2,000;
(V) in the case of a fifth violation
within a 36-month period, $5,000; and
(VI) in the case of a sixth or
subsequent violation within a 48-month
period, $10,000 as determined by the
Secretary on a case-by-case basis.
[[Page 123 STAT. 1840]]
(ii) With respect to a retailer that does not
have an approved training program, the amount of
the civil penalty shall not exceed--
(I) in the case of the first
violation, $250;
(II) in the case of a second
violation within a 12-month period,
$500;
(III) in the case of a third
violation within a 24-month period,
$1,000;
(IV) in the case of a fourth
violation within a 24-month period,
$2,000;
(V) in the case of a fifth violation
within a 36-month period, $5,000; and
(VI) in the case of a sixth or
subsequent violation within a 48-month
period, $10,000 as determined by the
Secretary on a case-by-case basis.
(B) Training program.--For purposes of subparagraph
(A), the term ``approved training program'' means a
training program that complies with standards developed
by the Food and Drug Administration for such programs.
(C) Consideration of state penalties.--The Secretary
shall coordinate with the States in enforcing the
provisions of this Act and, for purposes of mitigating a
civil penalty to be applied for a violation by a
retailer of any restriction promulgated under section
906(d), shall consider the amount of any penalties paid
by the retailer to a State for the same violation.
(3) <<NOTE: 21 USC 333 note.>> General effective date.--The
amendments made by paragraphs (2), (3), and (4) of subsection
(c) shall take effect upon the issuance of guidance described in
paragraph (1) of this subsection.
(4) <<NOTE: 21 USC 333 note.>> Special effective date.--The
amendment made by subsection (c)(1) shall take effect on the
date of enactment of this Act.
(5) <<NOTE: 21 USC 387c note.>> Package label
requirements.--The package label requirements of paragraphs (3)
and (4) of section 903(a) of the Federal Food, Drug, and
Cosmetic Act (as amended by this division) shall take effect on
the date that is 12 months after the date of enactment of this
Act. The package label requirements of paragraph (2) of such
section 903(a) for cigarettes shall take effect on the date that
is 15 months after the issuance of the regulations required by
section 4(d) of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1333), as amended by section 201 of this
division. The package label requirements of paragraph (2) of
such section 903(a) for tobacco products other than cigarettes
shall take effect on the date that is 12 months after the date
of enactment of this Act. The effective date shall be with
respect to the date of manufacture, provided that, in any case,
beginning 30 days after such effective date, a manufacturer
shall not introduce into the domestic commerce of the United
States any product, irrespective of the date of manufacture,
that is not in conformance with section 903(a) (2), (3), and (4)
and section 920(a) of the Federal Food, Drug, and Cosmetic Act.
(6) Advertising requirements.--The advertising requirements
of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act
(as amended by this division) shall take effect on
[[Page 123 STAT. 1841]]
the date that is 12 months after the date of enactment of this
Act.
SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PURCHASE TOBACCO
PRODUCTS.
The Secretary of Health and Human Services shall--
(1) convene an expert panel to conduct a study on the public
health implications of raising the minimum age to purchase
tobacco products; and
(2) not <<NOTE: Deadline. Reports.>> later than 5 years
after the date of enactment of this Act, submit a report to the
Congress on the results of such study.
SEC. 105. <<NOTE: 21 USC 387f-1.>> ENFORCEMENT ACTION PLAN FOR
ADVERTISING AND PROMOTION RESTRICTIONS.
(a) Action Plan.--
(1) Development.--Not
later <<NOTE: Deadline. Publication.>> than 6 months after the
date of enactment of this Act, the Secretary of Health and Human
Services (in this section referred to as the ``Secretary'')
shall develop and publish an action plan to enforce restrictions
adopted pursuant to section 906 of the Federal Food, Drug, and
Cosmetic Act, as added by section 101(b) of this division, or
pursuant to section 102(a) of this division, on promotion and
advertising of menthol and other cigarettes to youth.
(2) Consultation.--The action plan required by paragraph (1)
shall be developed in consultation with public health
organizations and other stakeholders with demonstrated expertise
and experience in serving minority communities.
(3) Priority.--The action plan required by paragraph (1)
shall include provisions designed to ensure enforcement of the
restrictions described in paragraph (1) in minority communities.
(b) State and Local Activities.--
(1) Information on authority.--Not
later <<NOTE: Deadline.>> than 3 months after the date of
enactment of this Act, the Secretary shall inform State, local,
and tribal governments of the authority provided to such
entities under section 5(c) of the Federal Cigarette Labeling
and Advertising Act, as added by section 203 of this division,
or preserved by such entities under section 916 of the Federal
Food, Drug, and Cosmetic Act, as added by section 101(b) of this
division.
(2) Community assistance.--At the request of communities
seeking assistance to prevent underage tobacco use, the
Secretary shall provide such assistance, including assistance
with strategies to address the prevention of underage tobacco
use in communities with a disproportionate use of menthol
cigarettes by minors.
SEC. 106. <<NOTE: 21 USC 387u.>> STUDIES OF PROGRESS AND
EFFECTIVENESS.
(a) FDA Report.--Not later than 3 years after the date of enactment
of this Act, and not less than every 2 years thereafter, the Secretary
of Health and Human Services shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, a report concerning--
(1) the progress of the Food and Drug Administration in
implementing this division, including major accomplishments,
objective measurements of progress, and the identification of
any areas that have not been fully implemented;
[[Page 123 STAT. 1842]]
(2) impediments identified by the Food and Drug
Administration to progress in implementing this division and to
meeting statutory timeframes;
(3) data on the number of new product applications received
under section 910 of the Federal Food, Drug, and Cosmetic Act
and modified risk product applications received under section
911 of such Act, and the number of applications acted on under
each category; and
(4) data on the number of full time equivalents engaged in
implementing this division.
(b) GAO Report.--Not later <<NOTE: Study.>> than 5 years after the
date of enactment of this Act, the Comptroller General of the United
States shall conduct a study of, and submit to the Committees described
in subsection (a) a report concerning--
(1) the adequacy of the authority and resources provided to
the Secretary of Health and Human Services for this division to
carry out its goals and purposes; and
(2) any recommendations for strengthening that authority to
more effectively protect the public health with respect to the
manufacture, marketing, and distribution of tobacco products.
(c) Public Availability.--The Secretary <<NOTE: Web posting.>> of
Health and Human Services and the Comptroller General of the United
States, respectively, shall make the reports required under subsection
(a) and (b) available to the public, including by posting such reports
on the respective Internet websites of the Food and Drug Administration
and the Government Accountability Office.
TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.
(a) Amendment.--Section 4 of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1333) is amended to read as follows:
``SEC. 4. LABELING.
``(a) Label Requirements.--
``(1) In general.--It shall be unlawful for any person to
manufacture, package, sell, offer to sell, distribute, or import
for sale or distribution within the United States any cigarettes
the package of which fails to bear, in accordance with the
requirements of this section, one of the following labels:
``WARNING: Cigarettes are addictive.
``WARNING: Tobacco smoke can harm your children.
``WARNING: Cigarettes cause fatal lung disease.
``WARNING: Cigarettes cause cancer.
``WARNING: Cigarettes cause strokes and heart
disease.
``WARNING: Smoking during pregnancy can harm your
baby.
``WARNING: Smoking can kill you.
``WARNING: Tobacco smoke causes fatal lung disease
in nonsmokers.
[[Page 123 STAT. 1843]]
``WARNING: Quitting smoking now greatly reduces
serious risks to your health.
``(2) Placement; typography; etc.--Each label statement
required by paragraph (1) shall be located in the upper portion
of the front and rear panels of the package, directly on the
package underneath the cellophane or other clear wrapping. Each
label statement shall comprise the top 50 percent of the front
and rear panels of the package. The word `WARNING' shall appear
in capital letters and all text shall be in conspicuous and
legible 17-point type, unless the text of the label statement
would occupy more than 70 percent of such area, in which case
the text may be in a smaller conspicuous and legible type size,
provided that at least 60 percent of such area is occupied by
required text. The text shall be black on a white background, or
white on a black background, in a manner that contrasts, by
typography, layout, or color, with all other printed material on
the package, in an alternating fashion under the plan submitted
under subsection (c).
``(3) Does not apply to foreign distribution.--The
provisions of this subsection do not apply to a tobacco product
manufacturer or distributor of cigarettes which does not
manufacture, package, or import cigarettes for sale or
distribution within the United States.
``(4) Applicability to retailers.--A retailer of cigarettes
shall not be in violation of this subsection for packaging
that--
``(A) contains a warning label;
``(B) is supplied to the retailer by a license- or
permit-holding tobacco product manufacturer, importer,
or distributor; and
``(C) is not altered by the retailer in a way that
is material to the requirements of this subsection.
``(b) Advertising Requirements.--
``(1) In general.--It shall be unlawful for any tobacco
product manufacturer, importer, distributor, or retailer of
cigarettes to advertise or cause to be advertised within the
United States any cigarette unless its advertising bears, in
accordance with the requirements of this section, one of the
labels specified in subsection (a).
``(2) Typography, etc.--Each label statement required by
subsection (a) in cigarette advertising shall comply with the
standards set forth in this paragraph. For press and poster
advertisements, each such statement and (where applicable) any
required statement relating to tar, nicotine, or other
constituent (including a smoke constituent) yield shall comprise
at least 20 percent of the area of the advertisement and shall
appear in a conspicuous and prominent format and location at the
top of each advertisement within the trim area. The Secretary
may revise the required type sizes in such area in such manner
as the Secretary determines appropriate. The word `WARNING'
shall appear in capital letters, and each label statement shall
appear in conspicuous and legible type. The text of the label
statement shall be black if the background is white and white if
the background is black, under the plan submitted under
subsection (c). The label statements shall be enclosed by a
rectangular border that is the same color as the letters of the
statements and that is the width of the first downstroke of the
capital `W' of the word `WARNING'
[[Page 123 STAT. 1844]]
in the label statements. The text of such label statements shall
be in a typeface pro rata to the following requirements: 45-
point type for a whole-page broadsheet newspaper advertisement;
39-point type for a half-page broadsheet newspaper
advertisement; 39-point type for a whole-page tabloid newspaper
advertisement; 27-point type for a half-page tabloid newspaper
advertisement; 31.5-point type for a double page spread magazine
or whole-page magazine advertisement; 22.5-point type for a 28
centimeter by 3 column advertisement; and 15-point type for a 20
centimeter by 2 column advertisement. The label statements shall
be in English, except that--
``(A) in the case of an advertisement that appears
in a newspaper, magazine, periodical, or other
publication that is not in English, the statements shall
appear in the predominant language of the publication;
and
``(B) in the case of any other advertisement that is
not in English, the statements shall appear in the same
language as that principally used in the advertisement.
``(3) Matchbooks.--Notwithstanding paragraph (2), for
matchbooks (defined as containing not more than 20 matches)
customarily given away with the purchase of tobacco products,
each label statement required by subsection (a) may be printed
on the inside cover of the matchbook.
``(4) Adjustment by secretary.--The Secretary may, through a
rulemaking under section 553 of title 5, United States Code,
adjust the format and type sizes for the label statements
required by this section; the text, format, and type sizes of
any required tar, nicotine yield, or other constituent
(including smoke constituent) disclosures; or the text, format,
and type sizes for any other disclosures required under the
Federal Food, Drug, and Cosmetic Act. The text of any such label
statements or disclosures shall be required to appear only
within the 20 percent area of cigarette advertisements provided
by paragraph (2). <<NOTE: Regulations.>> The Secretary shall
promulgate regulations which provide for adjustments in the
format and type sizes of any text required to appear in such
area to ensure that the total text required to appear by law
will fit within such area.
``(c) Marketing Requirements.--
``(1) Random display.--The label <<NOTE: Time period.>>
statements specified in subsection (a)(1) shall be randomly
displayed in each 12-month period, in as equal a number of times
as is possible on each brand of the product and be randomly
distributed in all areas of the United States in which the
product is marketed in accordance with a plan submitted by the
tobacco product manufacturer, importer, distributor, or retailer
and approved by the Secretary.
``(2) Rotation.--The label <<NOTE: Deadline.>> statements
specified in subsection (a)(1) shall be rotated quarterly in
alternating sequence in advertisements for each brand of
cigarettes in accordance with a plan submitted by the tobacco
product manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(3) Review.--The Secretary shall review each plan
submitted under paragraph (2) and approve it if the plan--
[[Page 123 STAT. 1845]]
``(A) will provide for the equal distribution and
display on packaging and the rotation required in
advertising under this subsection; and
``(B) assures that all of the labels required under
this section will be displayed by the tobacco product
manufacturer, importer, distributor, or retailer at the
same time.
``(4) Applicability to retailers.--This subsection and
subsection (b) apply to a retailer only if that retailer is
responsible for or directs the label statements required under
this section except that this paragraph shall not relieve a
retailer of liability if the retailer displays, in a location
open to the public, an advertisement that does not contain a
warning label or has been altered by the retailer in a way that
is material to the requirements of this subsection and
subsection (b).
``(d) Graphic Label Statements.--Not
later <<NOTE: Deadline. Regulations.>> than 24 months after the date of
enactment of the Family Smoking Prevention and Tobacco Control Act, the
Secretary shall issue regulations that require color graphics depicting
the negative health consequences of smoking to accompany the label
statements specified in subsection (a)(1). The Secretary may adjust the
type size, text and format of the label statements specified in
subsections (a)(2) and (b)(2) as the Secretary determines appropriate so
that both the graphics and the accompanying label statements are clear,
conspicuous, legible and appear within the specified area.''.
(b) Effective Date.--The amendment <<NOTE: 15 USC 1333 note.>> made
by subsection (a) shall take effect 15 months after the issuance of the
regulations required by subsection (a). Such effective date shall be
with respect to the date of manufacture, provided that, in any case,
beginning 30 days after such effective date, a manufacturer shall not
introduce into the domestic commerce of the United States any product,
irrespective of the date of manufacture, that is not in conformance with
section 4 of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1333), as amended by subsection (a).
SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL STATEMENTS.
(a) Preemption.--Section 5(a) of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1334(a)) is amended by striking ``No'' and
inserting ``Except to the extent the Secretary requires additional or
different statements on any cigarette package by a regulation, by an
order, by a standard, by an authorization to market a product, or by a
condition of marketing a product, pursuant to the Family Smoking
Prevention and Tobacco Control Act (and the amendments made by that
Act), or as required under section 903(a)(2) or section 920(a) of the
Federal Food, Drug, and Cosmetic Act, no''.
(b) Change in Required Statements.--Section 4 of the Federal
Cigarette Labeling and Advertising Act (15 U.S.C. 1333), as amended by
section 201, is further amended by adding at the end the following:
``(d) Change in Required Statements.--The Secretary through a
rulemaking conducted under section 553 of title 5, United States Code,
may adjust the format, type size, color graphics, and text of any of the
label requirements, or establish the format, type size, and text of any
other disclosures required under the Federal Food, Drug, and Cosmetic
Act, if the Secretary finds that
[[Page 123 STAT. 1846]]
such a change would promote greater public understanding of the risks
associated with the use of tobacco products.''.
SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING AND PROMOTION.
Section 5 of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1334) is amended by adding at the end the following:
``(c) Exception.--Notwithstanding subsection (b), a State or
locality may enact statutes and promulgate regulations, based on smoking
and health, that take effect after the effective date of the Family
Smoking Prevention and Tobacco Control Act, imposing specific bans or
restrictions on the time, place, and manner, but not content, of the
advertising or promotion of any cigarettes.''.
SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.
(a) Amendment.--Section 3 of the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4402) is amended to read as
follows:
``SEC. 3. SMOKELESS TOBACCO WARNING.
``(a) General Rule.--
``(1) It shall be unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale or
distribution within the United States any smokeless tobacco
product unless the product package bears, in accordance with the
requirements of this Act, one of the following labels:
``WARNING: This product can cause mouth cancer.
``WARNING: This product can cause gum disease and
tooth loss.
``WARNING: This product is not a safe alternative to
cigarettes.
``WARNING: Smokeless tobacco is addictive.
``(2) Each label statement required by paragraph (1) shall
be--
``(A) located on the 2 principal display panels of
the package, and each label statement shall comprise at
least 30 percent of each such display panel; and
``(B) in 17-point conspicuous and legible type and
in black text on a white background, or white text on a
black background, in a manner that contrasts by
typography, layout, or color, with all other printed
material on the package, in an alternating fashion under
the plan submitted under subsection (b)(3), except that
if the text of a label statement would occupy more than
70 percent of the area specified by subparagraph (A),
such text may appear in a smaller type size, so long as
at least 60 percent of such warning area is occupied by
the label statement.
``(3) The label statements required by paragraph (1) shall
be introduced by each tobacco product manufacturer, packager,
importer, distributor, or retailer of smokeless tobacco products
concurrently into the distribution chain of such products.
``(4) The provisions of this subsection do not apply to a
tobacco product manufacturer or distributor of any smokeless
tobacco product that does not manufacture, package, or import
smokeless tobacco products for sale or distribution within the
United States.
[[Page 123 STAT. 1847]]
``(5) A retailer of smokeless tobacco products shall not be
in violation of this subsection for packaging that--
``(A) contains a warning label;
``(B) is supplied to the retailer by a license- or
permit-holding tobacco product manufacturer, importer,
or distributor; and
``(C) is not altered by the retailer in a way that
is material to the requirements of this subsection.
``(b) Required Labels.--
``(1) It shall be unlawful for any tobacco product
manufacturer, packager, importer, distributor, or retailer of
smokeless tobacco products to advertise or cause to be
advertised within the United States any smokeless tobacco
product unless its advertising bears, in accordance with the
requirements of this section, one of the labels specified in
subsection (a).
``(2)(A) Each label statement required by subsection (a) in
smokeless tobacco advertising shall comply with the standards
set forth in this paragraph.
``(B) For press and poster advertisements, each such
statement and (where applicable) any required statement relating
to tar, nicotine, or other constituent yield shall comprise at
least 20 percent of the area of the advertisement.
``(C) The word `WARNING' shall appear in capital letters,
and each label statement shall appear in conspicuous and legible
type.
``(D) The text of the label statement shall be black on a
white background, or white on a black background, in an
alternating fashion under the plan submitted under paragraph
(3).
``(E) The label statements shall be enclosed by a
rectangular border that is the same color as the letters of the
statements and that is the width of the first downstroke of the
capital `W' of the word `WARNING' in the label statements.
``(F) The text of such label statements shall be in a
typeface pro rata to the following requirements: 45-point type
for a whole-page broadsheet newspaper advertisement; 39-point
type for a half-page broadsheet newspaper advertisement; 39-
point type for a whole-page tabloid newspaper advertisement; 27-
point type for a half-page tabloid newspaper advertisement;
31.5-point type for a double page spread magazine or whole-page
magazine advertisement; 22.5-point type for a 28 centimeter by 3
column advertisement; and 15-point type for a 20 centimeter by 2
column advertisement.
``(G) The label statements shall be in English, except
that--
``(i) in the case of an advertisement that appears
in a newspaper, magazine, periodical, or other
publication that is not in English, the statements shall
appear in the predominant language of the publication;
and
``(ii) in the case of any other advertisement that
is not in English, the statements shall appear in the
same language as that principally used in the
advertisement.
``(3)(A) The label statements specified in subsection (a)(1)
shall be randomly displayed in each 12-month period, in as equal
a number of times as is possible on each brand of the product
and be randomly distributed in all areas of the United States in
which the product is marketed in accordance with
[[Page 123 STAT. 1848]]
a plan submitted by the tobacco product manufacturer, importer,
distributor, or retailer and approved by the Secretary.
``(B) The label statements specified in subsection (a)(1)
shall be rotated quarterly in alternating sequence in
advertisements for each brand of smokeless tobacco product in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(C) The Secretary shall review each plan submitted under
subparagraphs (A) and (B) and approve it if the plan--
``(i) will provide for the equal distribution and
display on packaging and the rotation required in
advertising under this subsection; and
``(ii) assures that all of the labels required under
this section will be displayed by the tobacco product
manufacturer, importer, distributor, or retailer at the
same time.
``(D) This <<NOTE: Applicability.>> paragraph applies to a
retailer only if that retailer is responsible for or directs the
label statements under this section, unless the retailer
displays, in a location open to the public, an advertisement
that does not contain a warning label or has been altered by the
retailer in a way that is material to the requirements of this
subsection.
``(4) The Secretary may, through a rulemaking under section
553 of title 5, United States Code, adjust the format and type
sizes for the label statements required by this section; the
text, format, and type sizes of any required tar, nicotine
yield, or other constituent disclosures; or the text, format,
and type sizes for any other disclosures required under the
Federal Food, Drug, and Cosmetic Act. The text of any such label
statements or disclosures shall be required to appear only
within the 20 percent area of advertisements provided by
paragraph (2). <<NOTE: Regulations.>> The Secretary shall
promulgate regulations which provide for adjustments in the
format and type sizes of any text required to appear in such
area to ensure that the total text required to appear by law
will fit within such area.
``(c) Television and Radio Advertising.--It is unlawful to advertise
smokeless tobacco on any medium of electronic communications subject to
the jurisdiction of the Federal Communications Commission.''.
(b) <<NOTE: 15 USC 4402 note.>> Effective Date.--The amendment made
by subsection (a) shall take effect 12 months after the date of
enactment of this Act. Such effective date shall be with respect to the
date of manufacture, provided that, in any case, beginning 30 days after
such effective date, a manufacturer shall not introduce into the
domestic commerce of the United States any product, irrespective of the
date of manufacture, that is not in conformance with section 3 of the
Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C.
4402), as amended by subsection (a).
SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT WARNING
LABEL STATEMENTS.
(a) In General.--Section 3 of the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4402), as amended by section
204, is further amended by adding at the end the following:
``(d) Authority To Revise Warning Label Statements.--The Secretary
may, by a rulemaking conducted under section 553
[[Page 123 STAT. 1849]]
of title 5, United States Code, adjust the format, type size, and text
of any of the label requirements, require color graphics to accompany
the text, increase the required label area from 30 percent up to 50
percent of the front and rear panels of the package, or establish the
format, type size, and text of any other disclosures required under the
Federal Food, Drug, and Cosmetic Act, if the Secretary finds that such a
change would promote greater public understanding of the risks
associated with the use of smokeless tobacco products.''.
(b) Preemption.--Section 7(a) of the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4406(a)) is amended by striking
``No'' and inserting ``Except as provided in the Family Smoking
Prevention and Tobacco Control Act (and the amendments made by that
Act), no''.
SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE TO
THE PUBLIC.
Section 4 of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1333), as amended by sections 201 and 202, is further amended by
adding at the end the following:
``(e) Tar, Nicotine, and Other Smoke Constituent Disclosure.--
``(1) In general.--The Secretary <<NOTE: Regulations.>>
shall, by a rulemaking conducted under section 553 of title 5,
United States Code, determine (in the Secretary's sole
discretion) whether cigarette and other tobacco product
manufacturers shall be required to include in the area of each
cigarette advertisement specified by subsection (b) of this
section, or on the package label, or both, the tar and nicotine
yields of the advertised or packaged brand. Any such disclosure
shall be in accordance with the methodology established under
such regulations, shall conform to the type size requirements of
subsection (b) of this section, and shall appear within the area
specified in subsection (b) of this section.
``(2) <<NOTE: Memorandum.>> Resolution of differences.--Any
differences between the requirements established by the
Secretary under paragraph (1) and tar and nicotine yield
reporting requirements established by the Federal Trade
Commission shall be resolved by a memorandum of understanding
between the Secretary and the Federal Trade Commission.
``(3) Cigarette and other tobacco product constituents.--In
addition to the disclosures required by paragraph (1), the
Secretary may, under a rulemaking conducted under section 553 of
title 5, United States Code, prescribe disclosure requirements
regarding the level of any cigarette or other tobacco product
constituent including any smoke constituent. Any such disclosure
may be required if the Secretary determines that disclosure
would be of benefit to the public health, or otherwise would
increase consumer awareness of the health consequences of the
use of tobacco products, except that no such prescribed
disclosure shall be required on the face of any cigarette
package or advertisement. Nothing in this section shall prohibit
the Secretary from requiring such prescribed disclosure through
a cigarette or other tobacco product package or advertisement
insert, or by any other means under the Federal Food, Drug, and
Cosmetic Act.
[[Page 123 STAT. 1850]]
``(4) Retailers.--This subsection <<NOTE: Applicability.>>
applies to a retailer only if that retailer is responsible for
or directs the label statements required under this section.''.
TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPECTION.
Chapter IX of the Federal Food, Drug, and Cosmetic Act, as added by
section 101, is further amended by adding at the end the following:
``SEC. 920. <<NOTE: 21 USC 387t.>> LABELING, RECORDKEEPING,
RECORDS INSPECTION.
``(a) Origin Labeling.--
``(1) Requirement.--Beginning 1 <<NOTE: Effective dates.>>
year after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, the label, packaging, and
shipping containers of tobacco products other than cigarettes
for introduction or delivery for introduction into interstate
commerce in the United States shall bear the statement `sale
only allowed in the United States'. Beginning 15 months after
the issuance of the regulations required by section 4(d) of the
Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333),
as amended by section 201 of Family Smoking Prevention and
Tobacco Control Act, the label, packaging, and shipping
containers of cigarettes for introduction or delivery for
introduction into interstate commerce in the United States shall
bear the statement `Sale only allowed in the United States'.
``(2) Effective date.--The effective date specified in
paragraph (1) shall be with respect to the date of manufacture,
provided that, in any case, beginning 30 days after such
effective date, a manufacturer shall not introduce into the
domestic commerce of the United States any product, irrespective
of the date of manufacture, that is not in conformance with such
paragraph.
``(b) Regulations Concerning Recordkeeping for Tracking and
Tracing.--
``(1) In general.--The Secretary shall promulgate
regulations regarding the establishment and maintenance of
records by any person who manufactures, processes, transports,
distributes, receives, packages, holds, exports, or imports
tobacco products.
``(2) Inspection.--In promulgating the regulations described
in paragraph (1), the Secretary shall consider which records are
needed for inspection to monitor the movement of tobacco
products from the point of manufacture through distribution to
retail outlets to assist in investigating potential illicit
trade, smuggling, or counterfeiting of tobacco products.
``(3) Codes.--The Secretary may require codes on the labels
of tobacco products or other designs or devices for the purpose
of tracking or tracing the tobacco product through the
distribution system.
``(4) Size of business.--The Secretary shall take into
account the size of a business in promulgating regulations under
this section.
[[Page 123 STAT. 1851]]
``(5) Recordkeeping by retailers.--The Secretary shall not
require any retailer to maintain records relating to individual
purchasers of tobacco products for personal consumption.
``(c) Records Inspection.--If the <<NOTE: Notice.>> Secretary has a
reasonable belief that a tobacco product is part of an illicit trade or
smuggling or is a counterfeit product, each person who manufactures,
processes, transports, distributes, receives, holds, packages, exports,
or imports tobacco products shall, at the request of an officer or
employee duly designated by the Secretary, permit such officer or
employee, at reasonable times and within reasonable limits and in a
reasonable manner, upon the presentation of appropriate credentials and
a written notice to such person, to have access to and copy all records
(including financial records) relating to such article that are needed
to assist the Secretary in investigating potential illicit trade,
smuggling, or counterfeiting of tobacco products. The Secretary shall
not authorize an officer or employee of the government of any of the
several States to exercise authority under the preceding sentence on
Indian country without the express written consent of the Indian tribe
involved.
``(d) Knowledge of Illegal Transaction.--
``(1) Notification.--If the manufacturer or distributor of a
tobacco product has knowledge which reasonably supports the
conclusion that a tobacco product manufactured or distributed by
such manufacturer or distributor that has left the control of
such person may be or has been--
``(A) imported, exported, distributed, or offered
for sale in interstate commerce by a person without
paying duties or taxes required by law; or
``(B) imported, exported, distributed, or diverted
for possible illicit marketing,
the manufacturer or distributor shall promptly notify the
Attorney General and the Secretary of the Treasury of such
knowledge.
``(2) Knowledge defined.--For purposes of this subsection,
the term `knowledge' as applied to a manufacturer or distributor
means--
``(A) the actual knowledge that the manufacturer or
distributor had; or
``(B) the knowledge which a reasonable person would
have had under like circumstances or which would have
been obtained upon the exercise of due care.
``(e) Consultation.--In carrying out this section, the Secretary
shall consult with the Attorney General of the United States and the
Secretary of the Treasury, as appropriate.''.
SEC. 302. STUDY AND REPORT.
(a) Study.--The Comptroller General of the United States shall
conduct a study of cross-border trade in tobacco products to--
(1) collect data on cross-border trade in tobacco products,
including illicit trade and trade of counterfeit tobacco
products and make recommendations on the monitoring of such
trade;
(2) collect data on cross-border advertising (any
advertising intended to be broadcast, transmitted, or
distributed from the United States to another country) of
tobacco products and make recommendations on how to prevent or
eliminate, and what technologies could help facilitate the
elimination of, cross-border advertising; and
[[Page 123 STAT. 1852]]
(3) collect data on the health effects (particularly with
respect to individuals under 18 years of age) resulting from
cross-border trade in tobacco products, including the health
effects resulting from--
(A) the illicit trade of tobacco products and the
trade of counterfeit tobacco products; and
(B) the differing tax rates applicable to tobacco
products.
(b) Report.--Not later than 18 months after the date of enactment of
this Act, the Comptroller General of the United States shall submit to
the Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of Representatives
a report on the study described in subsection (a).
(c) Definition.--In this section:
(1) The term ``cross-border trade'' means trade across a
border of the United States, a State or Territory, or Indian
country.
(2) The term ``Indian country'' has the meaning given to
such term in section 1151 of title 18, United States Code.
(3) The terms ``State'' and ``Territory'' have the meanings
given to those terms in section 201 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321).
DIVISION <<NOTE: Federal Retirement Reform Act of 2009.>> B--FEDERAL
RETIREMENT REFORM ACT
SEC. 100. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This division <<NOTE: 5 USC 101 note.>> may be
cited as the ``Federal Retirement Reform Act of 2009''.
(b) Table of Contents.--The table of contents for this division is
as follows:
DIVISION B--FEDERAL RETIREMENT REFORM ACT
Sec. 100. Short title; table of contents.
TITLE I--PROVISIONS RELATING TO FEDERAL EMPLOYEES RETIREMENT
Sec. 101. Short title.
Sec. 102. Automatic enrollments and immediate employing agency
contributions.
Sec. 103. Qualified Roth contribution program.
Sec. 104. Authority to establish mutual fund window.
Sec. 105. Reporting requirements.
Sec. 106. Acknowledgment of risk.
Sec. 107. Subpoena authority.
Sec. 108. Amounts in Thrift Savings Funds subject to legal proceedings.
Sec. 109. Accounts for surviving spouses.
Sec. 110. Treatment of members of the uniformed services under the
Thrift Savings Plan.
TITLE II--SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR SURVIVING SPOUSES OF
ARMED FORCES MEMBERS
Sec. 201. Increase in monthly amount of special survivor indemnity
allowance for widows and widowers of deceased members of the
Armed Forces affected by required Survivor Benefit Plan
annuity offset for dependency and indemnity compensation.
[[Page 123 STAT. 1853]]
TITLE <<NOTE: Thrift Savings Plan Enhancement Act of 2009.>> I--
PROVISIONS RELATING TO FEDERAL EMPLOYEES RETIREMENT
SEC. 101. <<NOTE: 5 USC 101 note.>> SHORT TITLE.
This title may be cited as the ``Thrift Savings Plan Enhancement Act
of 2009''.
SEC. 102. AUTOMATIC ENROLLMENTS AND IMMEDIATE EMPLOYING AGENCY
CONTRIBUTIONS.
(a) In General.--Section 8432(b) of title 5, United States Code, is
amended by striking paragraphs (2) through (4) and inserting the
following:
``(2)(A) The <<NOTE: Regulations.>> Executive Director shall by
regulation provide for an eligible individual to be automatically
enrolled to make contributions under subsection (a) at the default
percentage of basic pay.
``(B) For purposes of this paragraph, the default percentage shall
be equal to 3 percent or such other percentage, not less than 2 percent
nor more than 5 percent, as the Board may prescribe.
``(C) The regulations shall include provisions under which any
individual who would otherwise be automatically enrolled in accordance
with subparagraph (A) may--
``(i) modify the percentage or amount to be contributed
pursuant to automatic enrollment, effective not later than the
first full pay period following receipt of the election by the
appropriate processing entity; or
``(ii) decline automatic enrollment altogether.
``(D)(i) Except as provided in clause (ii), for purposes of this
paragraph, the term `eligible individual' means any individual who,
after any regulations under subparagraph (A) first take effect, is
appointed, transferred, or reappointed to a position in which that
individual becomes eligible to contribute to the Thrift Savings Fund.
``(ii) Members of the uniformed services shall not be eligible
individuals for purposes of this paragraph.
``(E) Sections <<NOTE: Applicability.>> 8351(a)(1), 8440a(a)(1),
8440b(a)(1), 8440c(a)(1), 8440d(a)(1), and 8440e(a)(1) shall be applied
in a manner consistent with the purposes of this paragraph.''.
(b) Technical Amendment.--Section 8432(b)(1) of title 5, United
States Code, is amended by striking the parenthetical matter in
subparagraph (B).
SEC. 103. QUALIFIED ROTH CONTRIBUTION PROGRAM.
(a) In General.--Subchapter III of chapter 84 of title 5, United
States Code, is amended by inserting after section 8432c the following:
``Sec. 8432d. Qualified Roth contribution program
``(a) Definitions.--For purposes of this section--
``(1) the term `qualified Roth contribution program' means a
program described in paragraph (1) of section 402A(b) of the
Internal Revenue Code of 1986 which meets the requirements of
paragraph (2) of such section; and
``(2) the terms `designated Roth contribution' and `elective
deferral' have the meanings given such terms in section 402A of
the Internal Revenue Code of 1986.
[[Page 123 STAT. 1854]]
``(b) Authority To Establish.--The Executive <<NOTE: Regulations.>>
Director shall by regulation provide for the inclusion in the Thrift
Savings Plan of a qualified Roth contribution program, under such terms
and conditions as the Board may prescribe.
``(c) Required Provisions.--The regulations under subsection (b)
shall include--
``(1) provisions under which an election to make designated
Roth contributions may be made--
``(A) by any individual who is eligible to make
contributions under section 8351, 8432(a), 8440a, 8440b,
8440c, 8440d, or 8440e; and
``(B) by any individual, not described in
subparagraph (A), who is otherwise eligible to make
elective deferrals under the Thrift Savings Plan;
``(2) any provisions which may, as a result of enactment of
this section, be necessary in order to clarify the meaning of
any reference to an `account' made in section 8432(f), 8433,
8434(d), 8435, 8437, or any other provision of law; and
``(3) any other provisions which may be necessary to carry
out this section.''.
(b) Clerical Amendment.--The analysis for chapter 84 of title 5,
United States Code, is amended by inserting after the item relating to
section 8432c the following:
``8432d. Qualified Roth contribution program.''.
SEC. 104. AUTHORITY TO ESTABLISH MUTUAL FUND WINDOW.
(a) In General.--Section 8438(b)(1) of title 5, United States Code,
is amended--
(1) in subparagraph (D), by striking ``and'' at the end;
(2) in subparagraph (E), by striking the period and
inserting ``; and''; and
(3) by adding after subparagraph (E) the following:
``(F) a service that enables participants to invest
in mutual funds, if the Board authorizes the mutual fund
window under paragraph (5).''.
(b) Requirements.--Section 8438(b) of title 5, United States Code,
is amended by adding at the end the following:
``(5)(A) The Board may authorize the addition of a mutual fund
window under the Thrift Savings Plan if the Board determines that such
addition would be in the best interests of participants.
``(B) The Board shall ensure that any expenses charged for use of
the mutual fund window are borne solely by the participants who use such
window.
``(C) The Board may establish such other terms and conditions for
the mutual fund window as the Board considers appropriate to protect the
interests of participants, including requirements relating to risk
disclosure.
``(D) The <<NOTE: Consultation.>> Board shall consult with the
Employee Thrift Advisory Council (established under section 8473) before
authorizing the addition of a mutual fund window or establishing a
service that enables participants to invest in mutual funds.''.
(c) Technical and Conforming Amendment.--Section 8438(d)(1) of title
5, United States Code, is amended by inserting ``and options'' after
``investment funds''.
[[Page 123 STAT. 1855]]
SEC. 105. <<NOTE: 5 USC 8439 note.>> REPORTING REQUIREMENTS.
(a) Annual Report.--The Board shall, not later than June 30 of each
year, submit to Congress an annual report on the operations of the
Thrift Savings Plan. Such report shall include, for the prior calendar
year, information on the number of participants as of the last day of
such prior calendar year, the median balance in participants' accounts
as of such last day, demographic information on participants, the
percentage allocation of amounts among investment funds or options, the
status of the development and implementation of the mutual fund window,
the diversity demographics of any company, investment adviser, or other
entity retained to invest and manage the assets of the Thrift Savings
Fund, and such other information as the Board considers appropriate.
A <<NOTE: Public information. Web posting.>> copy of each annual report
under this subsection shall be made available to the public through an
Internet website.
(b) Reporting of Fees and Other Information.--
(1) In general.--The Board shall include in the periodic
statements provided to participants under section 8439(c) of
title 5, United States Code, the amount of the investment
management fees, administrative expenses, and any other fees or
expenses paid with respect to each investment fund and option
under the Thrift Savings Plan. <<NOTE: Notification.>> Any such
statement shall also provide a statement notifying participants
as to how they may access the annual report described in
subsection (a), as well as any other information concerning the
Thrift Savings Plan that might be useful.
(2) Use of estimates.--For purposes of providing the
information required under this subsection, the Board may
provide a reasonable and representative estimate of any fees or
expenses described in paragraph (1) and shall indicate any such
estimate as being such an estimate. Any such estimate shall be
based on the previous year's experience.
(c) Definitions.--For purposes of this section--
(1) the term ``Board'' has the meaning given such term by
8401(5) of title 5, United States Code;
(2) the term ``participant'' has the meaning given such term
by section 8471(3) of title 5, United States Code; and
(3) the term ``account'' means an account established under
section 8439 of title 5, United States Code.
SEC. 106. ACKNOWLEDGMENT OF RISK.
(a) In General.--Section 8439(d) of title 5, United States Code, is
amended--
(1) by striking the matter after ``who elects to invest in''
and before ``shall sign an acknowledgment'' and inserting ``any
investment fund or option under this chapter, other than the
Government Securities Investment Fund,''; and
(2) by striking ``either such Fund'' and inserting ``any
such fund or option''.
(b) Coordination With Provisions Relating to Fiduciary
Responsibilities, Liabilities, and Penalties.--Section 8477(e)(1)(C) of
title 5, United States Code, is amended--
(1) by redesignating subparagraph (C) as subparagraph
(C)(i); and
(2) by adding at the end the following:
``(ii) A fiduciary shall not be liable under subparagraph (A), and
no civil action may be brought against a fiduciary--
[[Page 123 STAT. 1856]]
``(I) for providing for the automatic enrollment of a
participant in accordance with section 8432(b)(2)(A);
``(II) for enrolling a participant in a default investment
fund in accordance with section 8438(c)(2); or
``(III) for allowing a participant to invest through the
mutual fund window or for establishing restrictions applicable
to participants' ability to invest through the mutual fund
window.''.
SEC. 107. SUBPOENA AUTHORITY.
(a) In General.--Chapter 84 of title 5, United States Code, is
amended by inserting after section 8479 the following:
``Sec. 8480. Subpoena authority
``(a) In order to carry out the responsibilities specified in this
subchapter and subchapter III of this chapter, the Executive Director
may issue subpoenas commanding each person to whom the subpoena is
directed to produce designated books, documents, records, electronically
stored information, or tangible materials in the possession or control
of that individual.
``(b) Notwithstanding any Federal, State, or local law, any person,
including officers, agents, and employees, receiving a subpoena under
this section, who complies in good faith with the subpoena and thus
produces the materials sought, shall not be liable in any court of any
State or the United States to any individual, domestic or foreign
corporation or upon a partnership or other unincorporated association
for such production.
``(c) When a person fails to obey a subpoena issued under this
section, the district court of the United States for the district in
which the investigation is conducted or in which the person failing to
obey is found, shall on proper application issue an order directing that
person to comply with the subpoena. The court may punish as contempt any
disobedience of its order.
``(d) The <<NOTE: Regulations.>> Executive Director shall prescribe
regulations to carry out subsection (a).''.
(b) Technical and Conforming Amendment.--The table of sections for
chapter 84 of title 5, United States Code, is amended by inserting after
the item relating to section 8479 the following:
``8480. Subpoena authority.''.
SEC. 108. AMOUNTS IN THRIFT SAVINGS FUNDS SUBJECT TO LEGAL
PROCEEDINGS.
Section 8437(e)(3) of title 5, United States Code, is amended in the
first sentence by striking ``or relating to the enforcement of a
judgment for the physically, sexually, or emotionally abusing a child as
provided under section 8467(a)'' and inserting ``the enforcement of an
order for restitution under section 3663A of title 18, forfeiture under
section 8432(g)(5) of this title, or an obligation of the Executive
Director to make a payment to another person under section 8467 of this
title''.
SEC. 109. ACCOUNTS FOR SURVIVING SPOUSES.
Section 8433(e) of title 5, United States Code, is amended--
(1) by inserting ``(1)'' after ``(e)''; and
(2) by adding at the end the following:
``(2) Notwithstanding section 8424(d), if an employee, Member,
former employee, or former Member dies and has designated as
[[Page 123 STAT. 1857]]
sole or partial beneficiary his or her spouse at the time of death, or,
if an employee, Member, former employee, or former Member, dies with no
designated beneficiary and is survived by a spouse, the spouse may
maintain the portion of the employee's or Member's account to which the
spouse is entitled in accordance with the following terms:
``(A) Subject to the limitations of subparagraph (B), the
spouse shall have the same withdrawal options under subsection
(b) as the employee or Member were the employee or Member
living.
``(B) The spouse may not make withdrawals under subsection
(g) or (h).
``(C) The spouse may not make contributions or transfers to
the account.
``(D) The account shall be disbursed upon the death of the
surviving spouse. A beneficiary or surviving spouse of a
deceased spouse who has inherited an account is ineligible to
maintain the inherited spousal account.
``(3) The <<NOTE: Regulations.>> Executive Director shall prescribe
regulations to carry out this subsection.''.
SEC. 110. TREATMENT OF MEMBERS OF THE UNIFORMED SERVICES UNDER THE
THRIFT SAVINGS PLAN.
(a) Sense of Congress.--It is the sense of Congress that--
(1) members of the uniformed services should have a
retirement system that is at least as generous as the one which
is available to Federal civilian employees; and
(2) Federal civilian employees receive matching
contributions from their employing agencies for their
contributions to the Thrift Savings Fund, but the costs of
requiring such a matching contribution from the Department of
Defense could be significant.
(b) Reporting Requirement.--Not later than 180 days after the date
of the enactment of this Act, the Secretary of Defense shall report to
Congress on--
(1) the cost to the Department of Defense of providing a
matching payment with respect to contributions made to the
Thrift Savings Fund by members of the Armed Forces;
(2) the effect that requiring such a matching payment would
have on recruitment and retention; and
(3) any other information that the Secretary of Defense
considers appropriate.
TITLE II--SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR SURVIVING SPOUSES OF
ARMED FORCES MEMBERS
SEC. 201. INCREASE IN MONTHLY AMOUNT OF SPECIAL SURVIVOR INDEMNITY
ALLOWANCE FOR WIDOWS AND WIDOWERS OF
DECEASED MEMBERS OF THE ARMED FORCES
AFFECTED BY REQUIRED SURVIVOR BENEFIT PLAN
ANNUITY OFFSET FOR DEPENDENCY AND
INDEMNITY COMPENSATION.
(a) Payment Amount Per Fiscal Year.--Paragraph (2) of section
1450(m) of title 10, United States Code, is amended--
[[Page 123 STAT. 1858]]
(1) in subparagraph (E), by striking ``and'' after the
semicolon; and
(2) by striking subparagraph (F) and inserting the following
new subparagraphs:
``(F) for months during fiscal year 2014, $150;
``(G) for months during fiscal year 2015, $200;
``(H) for months during fiscal year 2016, $275; and
``(I) for months during fiscal year 2017, $310.''.
(b) Duration.--Paragraph (6) of such section is amended--
(1) by striking ``February 28, 2016'' and inserting
``September 30, 2017''; and
(2) by striking ``March 1, 2016'' both places it appears and
inserting ``October 1, 2017''.
Approved June 22, 2009.
LEGISLATIVE HISTORY--H.R. 1256:
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HOUSE REPORTS: No. 111-58, Pt. 1 (Comm. on Energy and Commerce) and
Pt. 2 (Comm. on Oversight and Government Reform).
CONGRESSIONAL RECORD, Vol. 155 (2009):
Apr. 1, 2, considered and passed House.
June 3, 4, 8-11, considered and passed Senate, amended.
June 12, House concurred in Senate amendment.
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2009):
June 22, Presidential remarks.
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